Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Leiomyoma

Myofibroma

Disease Progression

Hyperinsulinism

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Donna D Baird, Ph.D.

The proposed study is designed to estimate the proportion of 35-49 year-old women in a large urban health plan who have had fibroids. The membership of the health plan is approximately 45% black, so estimates for black and white women can be compared. Risk factors for the condition will be studied, and uterine tissue from women having hysterectomies or myomectomies will be studied to identify genetic, hormonal, and protein mediators of tumor growth.

A randomly selected sample of about 1800 women age 35-49 who are members of the George Washington University Health Plan will be invited to participate. Presence of leiomyomas for premenopausal participants with no prior diagnosis of leiomyoma will be determined by an ultrasound examination. Presence of leiomyomas for premenopausal women who report a prior diagnosis of fibroids will be determined by ultrasound evidence in their medical record when available, and by self-report when not available. History of fibroids in postmenopausal women will be based on pathology records for those with surgical menopause and on radiology records or self-report for the small number of naturally postmenopausal women. Estimates of the proportion who have or have had fibroids will be compared for blacks and whites.

To examine risk factors for leiomyoma we will conduct a case-control analysis. Cases will be those women identified with leiomyoma from the random sample, supplemented by women in the same age range who have hysterectomies or myomectomies during the study period and hose excised uteri show evidence of fibroids on standard pathology examination. Women from the random sample with ultrasound or pathology evidence showing no uterine fibroids will constitute the control group. Controls will be compared to cases grouped by size of largest fibroid and grouped by clinical.

A telephone interview and self-administered questionnaire will provide information on demographic factors, medical history, dietary intake, reproductive history, life style factors, and occupational/environmental exposures. Blood will be collected from premenopausal women to measure lipids, insulin, and potential susceptibility genes. Urine will also be collected from premenopausal women early in their menstrual cycles to measure gonadotropin levels. Blood pressure, heart rate, weight, height, and waist-to-hip ration will be measured. Tissue from surgical specimens will be use by collaborators at NIEHS to measure cell proliferation and apoptosis, genetic factors, estrogen and progesterone receptor levels, protein markers of estrogen action, and growth factors.

Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Leiomyoma is a common condition with many tumors being asymptomatic. It is not known which women who have fibroids will develop clinical symptoms. In 1996-1999 the NIEHS Uterine Fibroid Study enrolled 1245 randomly selected premenopausal women, aged 35 to 49, who had been randomly selected from the membership roles of George Washington University Health Plan, a large prepaid health plan in Washington, D.C. Slightly over half of the participants were African American. Participants were asked about prior diagnoses of uterine leiomyomas, and 87% were examined by abdominal/transvaginal ultrasound to screen for uterine leiomyoma. Sixty-two percent of the 1245 had either had a prior diagnosis of leiomyoma or had sonogram evidence of the condition.

Study Objectives:

1. Monitor fibroid-related symptoms over time (Two follow-ups over a five-year period).
2. Measure the proportion of women who undergo major medical intervention (hysteroscopic resection, uterine artery embolization, laser coagulation, myomectomy, or hysterectomy).
3. Identify risk factors for increased symptom severity.
4. Identify risk factors for treatment intervention.

Methods: Premenopausal participants in the Uterine Fibroid Study (1996-1999) will be recontacted twice during the years 2001 - 2005 to obtain information about leiomyoma-related symptoms and medical or surgical treatments. Data will be collected with a computer-assisted telephone interview. Medical records of ultrasound or MRI examinations and major medical or surgical interventions will be abstracted to verify medical follow-up and treatment.

Significance: The presence of leiomyomas can be identified with ultrasound screening when the condition is asymptomatic. However, no data are available that allow clinicians to predict which women will experience morbidity. This longitudinal study will trace disease progression, and identify factors related to increased symptom severity and medical/surgical treatment. The findings could then be used to develop a systematic scoring system that can be used to identify women at high risk.

Risk Factors for Uterine Fibroids: A Case Control Study

Risk Factors for Uterine Fibroids: A Case Control Study and Follow-up Amendment to Study Disease Progression

National Institute of Environmental Health Sciences (NIEHS)

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Congenital Abnormalities

Polycystic Ovary Syndrome

Insulin Resistance

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Hypoglycemic Agents

Herbal and Botanical

Ethanol

Insulin

Insulin, Globin Zinc

Time-restricted eating using 18:6 protocol (12 weeks)

Washout Period (4 weeks)

Crossover to Normal ad libitum diet (12 weeks)

Normal ad libitum dietary patterns without defined eating window, fasting or restrictions on types of food or drink consumed (12 weeks)

Washout Period (4 weeks)

Crossover to time-restricted eating using 18:6 protocol (12 weeks)

Following a 3 day baseline dietary assessment using the Nutritics 'app', patients will immediately commence time-restricted eating on a 18:6 basis (18 hours fasting, 6 hours eating window) for 12 weeks.

Participants will consume all their meals within a daily 6-hour period of their choosing, and this may change according to patient's lifestyle and preference to reflect a real-world situation. Participants may eat ad libitum / according to appetite during the eating period. Participants will fast for 18 hours per day, consuming only plain water, unflavoured/unsweetened sparkling water, black breakfast tea or black coffee. Alcohol must not be consumed during fasting periods

Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12).

Time restricted eating

Following a 3-day baseline dietary assessment using the Nutritics 'app', participants with be directed to continue with their usual dietary intake without any time-related restrictions for 12 weeks. There will be no defined eating window and fasting or restrictions regarding types of food or drink consumed.

Dietary intake will again be measured using the Nutritics 'app' midpoint through the 12-week period (week 6 +/- 1 week) and in the last week of the intervention (week 11/12).

Normal ad libitum diet

Ruairí Floyd, BSc BMBS

Lucy-Ann Behan, MD

Sinead Duggan, R.D. PhD

Polycystic ovarian syndrome (PCOS) is associated with metabolic symptoms such as hyperinsulinemia. Time-restricted eating may reduce serum insulin and improve insulin resistance in patients with PCOS. Currently, there are few studies investigating time-restricted eating in patients with PCOS. The investigators plan to test the feasibility of time-restricted eating in the management of PCOS by means of a real-world clinical intervention. The investigators will determine if an 18:6 eating protocol reduces insulin levels by means of a randomised controlled crossover trial.

Background: Polycystic ovarian syndrome (PCOS) is the most common reproductive endocrinopathy in women of reproductive age with many associated metabolic symptoms, in particular hyperinsulinemia, insulin resistance and a high lifetime risk of type 2 diabetes mellitus. The effects of time-restricted eating on metabolic profiles have been investigated in many endocrinopathies, but there are minimal data in PCOS.

Methods: This study will investigate the feasibility of time-restricted eating in the management of PCOS, and its effects on insulin levels and other metabolic parameters.

To achieve this, the investigators will recruit 20 patients with PCOS (normal weight, overweight, obese).

In a randomised cross-over design, participants will be observed for two consecutive 12 week periods (with a 4 weeks washout period in between) following either 'time-restricted eating' or 'usual eating', detailed below.

1. 18:6 protocol: 18 hours of fasting and a 6-hours eating window, with no other specific dietary advice. Participants choose their own 6-hour period according to their lifestyle and preference.
2. Usual eating: follow usual eating patterns, no time restriction, no other dietary advice

When fasting, participants are permitted to consume plain water, unflavoured/unsweetened sparkling water, black breakfast tea and black coffee.

Dietary intake will be determined at baseline, at midpoint of each study arm, and at the end of the study using Nutritics software. Participants will self-record dietary intake using the Nutritics 'app'.

The primary endpoints will be serum insulin and feasibility of the intervention as well as safety, acceptability, and compliance with time-restricted eating.

Secondary endpoints will be insulin resistance (Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)), androgens (testosterone, free testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, 17-Hydroxyprogesterone (17-OHP) and sex hormone binding globulin (SHBG)), appetite (10-point visual analogue scale), hunger/satiety (glucagon-like peptide 1 (GLP-1), grehlin, PYY and oxyntomodulin, fasting glucose, HbA1c, lipid profile, lipoprotein lipid A, apolipoprotein A1, apolipoprotein B, anthropometrics (weight, body mass index, hip and waist circumference), dietary intake (calorie and macronutrient intake; micronutrient intake including iron, calcium; dietary pattern including timing).

Results: Safety and acceptability will be measured by adverse event reporting and measurement of adherence. Paired t-test will be used to assess between baseline and post intervention measurements. Results considered statistically significant if p\<0.05.

Discussion: Time-restricted eating has potential to aid in improvement of insulin resistance in patients with PCOS based on studies in other populations. There is no substantial literature on this subject to date in the PCOS patient cohort, with this being the first randomised study to date. The investigators will discuss the effects of time-restricted eating on insulin levels in the specific population of women with PCOS based on the results.

Time-restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome

The Effect of Time-restricted Eating on Insulin Levels and Other Metabolic Abnormalities in Polycystic Ovarian Syndrome: A Randomised Feasibility Study of Real-world Clinical Advice

Measured with serum insulin levels to assess effects

Assessment of change of eating behaviours

Assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and other ratio calculations measuring insulin resistance

Assessed by plasma dehydroepiandrosterone sulfate (DHEA-S)

Assessed by plasma sex hormone binding globulin (SHBG)

Assessed by plasma sex hormone binding globulin (SHBG))

Assessed by 17-Hydroxyprogesterone (17-OHP)

Measured by a validated 10-point visual analogue scale on a scale of 1-10, 1 being not hungry at all and 10 being very hungry

Assessed using interval dietary assessments with Nutritics 'app'

Tallaght University Hospital

Ruairí Floyd

Study Co-ordinator and Researcher

Immune System Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Hypersensitivity

Glucose Intolerance

Hyperglycemia

Other Dietary Supplements

Benzocaine

Tannic Acid

40 women with PCOS followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (40% carbohydrates, 25% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

35 individuals with Impaired Glucose Tolerance (IGT) followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

12 individuals diagnosed with type 2 diabetes followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.

Isocaloric diet with 3 meals

Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.

Isocaloric diet with 6 meals

Aimilia Papakonstantinou, PhD

Meropi Kontogianni, PhD

This study investigated any potential associations between two isocaloric diets with different meal frequency (3 meals versus 6 meals) and glycemic control in people at high diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.

The effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism) has been studied in several studies so far, both in healthy individuals and in individuals being at risk for diabetes mellitus, with or without concurrent weight loss. In addition, few studies have investigated the effect of different meal frequency on glycemic control in patients with diabetes mellitus under conditions of weight maintenance. However, the results regarding the ideal number of meals remain controversial.

To our best knowledge, there is no study available that has investigated the effect of meal frequency on glucose and insulin metabolism in lean and obese women with PCOS, in lean and obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese individuals with type 2 diabetes, independently of weight loss.

Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes

The Effects of Meal Frequency on Glucose, Insulin, and Insulin Sensitivity in Women With Polycystic Ovary Syndrome (PCOS), People at High Risk for Developing Type 2 Diabetes and People With Type 2 Diabetes

Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test.

Clinically useful change in serum insulin, defined as the restoration of insulin within normal limits during the 2-hour oral glucose tolerance test. Improved insulin sensitivity.

Normal serum levels of cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides.

Agricultural University of Athens

National and Kapodistrian University of Athens

Meropi Kontogianni

Assistant Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharmaceutical Solutions

Anabolic Androgenic Steroids

Amino-acid, glucose, and electrolyte solution

Parenteral Nutrition Solutions

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.

Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.

an amino acid supplementation infused intravenously containing essential and non-essential amino acids

Travasol (amino acid injection)

After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg\*min. Ten minuts after starting the insulin, and when the the blood glucose is\<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.

Thomas Schricker, MD

The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

The difference in total body protein after randomization to one of the three treatment arms.

Canadian Institutes of Health Research (CIHR)

McGill University Health Centre/Research Institute of the McGill University Health Centre

Chief of Anesthesia

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Obesity

Neoplasm Metastasis

Pituitary Diseases

Craniopharyngioma

Adamantinoma

Ameloblastoma

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Neuroepithelioma

Antihypertensive Agents

Vasodilator Agents

Diazoxide

DIAZOXIDE

Raja BRAUNER, MD,PhD

In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.

One major problem remains unsolved : the obesity

This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery

Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions

Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions

Assistance Publique - Hôpitaux de Paris

Isabelle BRINDEL

Heart and Blood Diseases

Hypertension

Adenoma

Bone Diseases, Metabolic

Hyperaldosteronism

Adrenocortical Adenoma

Adrenal Gland Neoplasms

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Endocrine Gland Neoplasms

Adenoma of the Adrenal Gland

Hyperadrenalism

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Adult individuals (age 18 or older) with HTN and discrete adrenal masses or bilateral hyperplasia of the adrenal glands, with outpatient positive ARR or string clinical suspicion for PA

DNA from relatives of patients (age 7 or older)

Sanaz Sakiani, M.D.

Background:

The adrenal gland makes the hormone aldosterone. This helps regulate blood pressure. An adrenal gland tumor that makes too much aldosterone can cause high blood pressure and low potassium. The cause of these tumors is unknown, but sometimes they are inherited.

Objective:

To study the genes that may cause primary aldosteronism in Black individuals.

Eligibility:

People ages 18-70 who:

Are Black, African American, or of Caribbean descent

And have difficult to control blood pressure or primary aldosteronism

Relatives of people with primary aldosteronism

Design:

Participants who are relatives of people with primary aldosteronism will have only 1 visit, with medical history and blood tests.

Participants with primary aldosteronism or difficult to control blood pressure (suspected to possibly have primary aldosteronism) will be screened with a 1-2 hour visit. If they qualify, they will return for a hospital stay for 7-10 days. Tests may include:

Medical history

Physical exam

Blood tests: Participants will have a small tube (IV catheter) inserted in a vein in the arm. They may drink a glucose-containing liquid or get a salt solution. If medically indicated, they may have invasive blood tests with a separate consent.

Urine tests: Some require a high-salt diet for 3 days.

Heart tests

Scans: Participants lie in a machine that takes pictures of the body. A dye may be injected through a vein.

Small hair sample taken from near the scalp.

Kidney ultrasound

Bone density scan: Participants lie on a table while a camera passes over the body.

If the doctors feel it is medically necessary, they will offer participants treatment depending on their results. These treatments may cure the patient of their disease and may include:

1. Having one adrenal gland removed by the Endocrine surgeon under anesthesia. Patients will have follow-up visits 2-4 weeks after surgery.
2. Taking drugs to block the effects of aldosterone

Participants may return about 1 year later to repeat testing....

Primary Aldosteronism (PA) is the most common cause of secondary hypertension, accounting for 6-8% of hypertension and 14-25% of resistant hypertension. This prevalence translates to approximately 1 in 30-50 adults or about 4,000,000 Americans with PA. Until recently, the deleterious effects of PA were thought to derive solely from aldosterone-mediated sodium retention and associated blood pressure rise. However, animal studies and clinical trials demonstrate that mineralocorticoid receptor (MR) blockade has cardio- and reno-protective effects that clearly exceed those expected from blood pressure reduction alone. Growing evidence supports the concept that excess aldosterone, in the presence of elevated blood pressure, initiates a cascade characterized by fibrosis, oxidative stress, and activation of pro-inflammatory and pro-fibrotic pathways, leading to morbidity via worsened insulin sensitivity, impaired bone formation, and accelerated cardiovascular remodeling. Recent studies have identified several new genetic underpinnings of PA, both germline and somatic, including mutations in KCNJ5, ATP1A1, ATP2B3, CACNA1D, and ARMC5. As the effects of chronic hyperaldosteronism differ between races, it is not surprising that the relative prevalence of these mutations differs among cohorts. African Americans (AA) in particular have increased susceptibility to end-organ damage from aldosterone excess-induced cardiovascular remodeling. They are more likely to have congestive heart failure, end-stage renal disease, and atherosclerotic events than age-matched Caucasians. However, to date no comprehensive analysis of mutations in PA has been performed in AA. (Note: for the purposes of this protocol, the terms Black or African American incorporate individuals who self-identify as Black, African American, or the Caribbean diaspora).

The aims of this study are to identify the germline and/or somatic mutations causing PA in AA, define the effects of these mutations on aldosterone production in AA, and to identify effective pharmacologic agents that will inhibit inappropriate aldosterone production in target cells. Aldosterone producing adenoma (APA) and other adrenocortical tumor (ACT) specimens will be gathered from archival (collected under protocol 00-CH-160 and other related NIH studies) and prospective research subjects with PA that will be evaluated at the NIH Clinical Research Center under the proposed protocol. Samples will be analyzed using state-of-the-art next-generation sequencing (NGS). Human adrenal cell lines (H295R and others, as appropriate) will be used to study the mutations effect on aldosterone production. Additionally, this will help identify possible effective pharmacologic therapeutics to treat PA. Animal models of novel genetic causes of PA may also be created to study the molecular mechanisms underpinning the disease.

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

define the causes of PA in AA and develop new therapeutic strategies to inhibit the inappropriate aldosterone production.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Metabolic Syndrome

Ali M Chappell, PhD, MS, RD

Ali M Chappell

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.

This study aims to investigate the significance of measuring fasting insulin and the homeostatic model assessment of insulin resistance (HOMA-IR) in identifying metabolic health across various demographic and clinical factors. Specifically, the study will examine the influence of age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis on insulin levels and insulin resistance as essential indicators of metabolic dysfunction.

Metabolic health disorders, such as insulin resistance and impaired glucose metabolism, are known to be associated with an increased risk of developing conditions like type 2 diabetes, cardiovascular diseases, and metabolic syndrome. Traditionally, glucose levels have been used to assess metabolic health; however, fasting insulin and HOMA-IR provide valuable insights into the underlying insulin dysregulation that precedes the onset of these conditions.

Disparities in insulin levels have been observed across different racial and ethnic groups. These variations may arise from genetic predispositions, differences in lifestyle, or a combination of both, thus highlighting the need to explore these factors comprehensively. BMI, a measure of body composition, has been strongly associated with elevated insulin levels and insulin resistance. Individuals with obesity often exhibit dysregulated insulin metabolism, leading to higher fasting insulin and HOMA-IR values. Furthermore, PCOS, a common endocrine disorder affecting reproductive-age women, is frequently associated with insulin resistance. Studying the insulin profiles among women with PCOS will shed light on the potential metabolic implications and help tailor interventions for this at-risk population.

The study will employ a cross-sectional design, enrolling a large sample of participants from diverse backgrounds. Fasting insulin levels will be measured using standardized laboratory methods, and HOMA-IR scores will be calculated based on fasting insulin and glucose values. Statistical analyses, including regression models and subgroup comparisons, will be conducted to assess the associations between fasting insulin, HOMA-IR, and the demographic and clinical factors of interest.

This research aims to emphasize the importance of incorporating fasting insulin and HOMA-IR measurements alongside glucose assessments to enhance the identification and understanding of metabolic health disorders. The findings are expected to contribute to a more comprehensive approach in diagnosing, managing, and preventing metabolic diseases, ultimately leading to improved patient outcomes and public health interventions.

Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

Measuring Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

The primary objective is to investigate the association between these measures and the specified demographic and clinical factors, providing insights into the variations and potential disparities in insulin resistance across different subgroups.

The secondary outcome measure will provide a comprehensive understanding of how various factors may influence insulin resistance and contribute to its heterogeneity in different populations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Risk Factors for Uterine Fibroids: A Case Control Study	NCT00339547	Uterine Fibroid...		35 Years - 50 Years	National Institutes of Health Clinical Center (CC)
Time-restricted Eating to Improve Metabolic Abnormalities in Polycystic Ovarian Syndrome	NCT05126199	PCOS Hyperinsulinemi... Insulin Resista...	Time restricted... Normal ad libit...	18 Years - 42 Years	Tallaght University Hospital
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	NCT02032953	Colorectal Canc...	Travasol (amino... Insulin	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions	NCT00306683	Hypothalamic-pi... Craniopharyngio...	DIAZOXIDE	6 Years - 18 Years	Assistance Publique - Hôpitaux de Paris
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks	NCT03374215	Adrenal Gland N... Hypertension Bone Diseases, ... Cardiovascular ... Hyperinsulinemi...		7 Years - 70 Years	National Institutes of Health Clinical Center (CC)
Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis	NCT05950282	Insulin Resista... Polycystic Ovar... Hyperinsulinism Obesity Metabolic Syndr...		18 Years -	Lilli Health

Spots Global Cancer Trial Database for hyperinsulinemia