Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Heart and Blood Diseases

Syndrome

Glucose Intolerance

Metabolic Diseases

Polycystic Ovary Syndrome

Insulin Resistance

Glucose Metabolism Disorders

Cardiac Complexes, Premature

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hyperglycemia

Hypoglycemic Agents

All Drugs and Chemicals

Hematinics

Insulin

Insulin, Globin Zinc

Liver Extracts

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

Oral glucose tolerance test (OGTT)

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

1H-magnetic resonance spectroscopy

Alexandra Kautzky-Willer, Univ.Prof.Dr.

In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.

In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.

Glucose Metabolism in Different PCOS Phenotypes

Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance

In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle.

Medical University of Vienna

Univ.Prof.Dr.

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Diabetes Mellitus

Obesity

Diabetes, Gestational

Hypersensitivity

Hyperandrogenism

Hyperinsulinism

Estrogens

Kai Cheang, Pharm. D.

The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. It is unknown if there are factors that may predict which women are more at risk.

The goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. Our long term goal is to contribute in finding ways to successfully prevent gestational diabetes.

The polycystic ovary syndrome is the leading cause of female infertility in the United States. The disorder affects approximately 6-10% of women of reproductive age. Insulin is a hormone that helps the body to take up sugar from the bloodstream. It is widely accepted that "insulin resistance" may be responsible for the polycystic ovary syndrome. Women are insulin resistant when their bodies do not respond to insulin's action to handle sugar as they normally should. Because of this insulin resistance, when women with the polycystic ovary syndrome become pregnant, they are at a higher risk of developing gestational diabetes. Gestational diabetes carries risk to both the mother and the baby. The purpose of this study is to determine whether certain factors in women with the polycystic ovary syndrome are linked to risk of gestational diabetes. We propose to look at demographic factors, as well as the body's handling of estrogen (a female hormone present in high quantities during pregnancy) in this study.

* blood sample
* blood sample sample for DNA
* fasting plasma for insulin, glucose, sex steroids (testosterone, androstenedione, DHEA-sulfate, estradiol, estrone, progesterone), sex hormone-binding globulin and estrogen metabolites
* blood sample for oral glucose tolerance test
* urine for estrogen metabolites

Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome

Insulin Resistance Before and During Pregnancy in Women With PCOS

National Institute on Minority Health and Health Disparities (NIMHD)

Virginia Commonwealth University

Rare Diseases

Anovulation

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Micronutrients

Other Dietary Supplements

Vitamins

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Inulin

Folate

Vitamin B9

Women with PCOS (N = 30) will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 1000 mg of myo-inositol and 25 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 2000 mg of myo-inositol and 50 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 3000 mg of myo-inositol and 75 mg of d-chiro-inositol) over the initial 3 mos RCT period.

Placebo

1gm/bid, 2gm/bid or 3gm/bid of Inositol powder

Amyee McMonagle, BSN

Sandra Eyer

Richard S. Legro, M.D.

Richard S Legro, M.D.

Claire Webb

Andrea Morley

Anuja Dokras, MD, PhD

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

This trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to CONSORT guidelines. This will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (SHBG)\], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.

Placebo Group; Active Treatment with Inositol 1gm/bid; Active Treatment with Inositol 2gm/bid; Active Treatment with Inositol 3gm/ bid

PCOS is a disorder that only affects women and therefore men are not eligible to participate in this study.

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

AUC of a 2-hour 75g glucose tolerance test, which measures glucose at 0, 30, 60, 90, and 120 minutes.

National Center for Complementary and Integrative Health (NCCIH)

Milton S. Hershey Medical Center

Chair, Obstetrics and Gynecology

Chronic Graft Versus Host Disease

Metformin

Folinic Acid

30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.

30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months

30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used myo-inositol 2g + folic acid 200mcg twice daily for 6 months, having a re-evaluation every 3 months.

Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.

Myo-inositol

30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin 850 mg twice a day for 6 months, having a re-evaluation every 3 months.

Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.

Edmund Chada Baracat, Phd

The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.

The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.

Comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin, orally, three times a day; Group II (experiment) - they will receive myo-inositol 2g, orally, twice a day.

Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome

Glucose tolerance curve with insulin curve will be performed every 3 months.

Glycated hemoglobin will be performed every 3 months.

Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.

Ultrasound of the ovaries will be done before and after treatment for antral follicle count (all follicles from 2 to 9 mm will be measured)

Body mass index (kg/m2) will be assessed every 3 months.

Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.

Patients will be weighed every 3 months (measured in kilograms).

Medication use diary will be delivered and will be reviewed every 3 months to assess adherence to treatment (good adherence will be considered use of more than 80% of the medication provided).

Questionnaire will be carried out every 3 months for patient to describe the 3 main side effects and how much they have hindered the treatment or not.

Initial liver ultrasound will be done and repeated after 6 months of treatment to assess the presence or absence of hepatic steatosis and classify it as mild (grade 1), moderate (grade 2) and severe (grade 3).

Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment

Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.

Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.

Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.

Serum dosage of the lipid profile (high density lipoprotein - HDL, low density lipoprotein - LDL , very low density lipoprotein - VLDL, triglycerides, total cholesterol) will be done every 3 months

Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.

Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glucose Metabolism in Different PCOS Phenotypes	NCT03204461	Polycystic Ovar... Glucose Intoler... Liver Fat Glucose Metabol...	Oral glucose to... 1H-magnetic res...	20 Years - 40 Years	Medical University of Vienna
Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome	NCT01475565	Polycystic Ovar... Insulin Resista... Insulin Sensiti... Obesity Pregnancy		18 Years - 40 Years	Virginia Commonwealth University
Glucose Metabolism in Different PCOS Phenotypes	NCT03204461	Polycystic Ovar... Glucose Intoler... Liver Fat Glucose Metabol...	Oral glucose to... 1H-magnetic res...	20 Years - 40 Years	Medical University of Vienna
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)	NCT03864068	Polycystic Ovar... Anovulation Hyperandrogenis... Insulin Resista... Glucose Intoler... Metabolic Compl...	Placebo Inositol	18 Years - 45 Years	Milton S. Hershey Medical Center
Effects of Myo-inositol in Women With Polycystic Ovary Syndrome	NCT04892186	Polycystic Ovar... Resistance, Ins... Glucose Intoler...	Myo-inositol Metformin	19 Years - 36 Years	University of Sao Paulo General Hospital
Effects of Myo-inositol in Women With Polycystic Ovary Syndrome	NCT04892186	Polycystic Ovar... Resistance, Ins... Glucose Intoler...	Myo-inositol Metformin	19 Years - 36 Years	University of Sao Paulo General Hospital

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