Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diabetes Mellitus, Type 2

Diabetes Mellitus

Syndrome

Obesity

Polycystic Ovary Syndrome

Insulin Resistance

Endometriosis

Fallopian Tube Diseases

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)

This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.

Manchi R Bharucha, Ph.D

Manchi R Bharucha, Ph.D.

Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.

Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.

Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.

Prevalence of HbA1C in Women With PCOS

Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study

HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS

Southern Cross Fertility Centre

Faram E.Irani

Karl-Heinz Wagner, PhD

Annemarie Grindel

Helmuth Brath, MD

The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients

Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

Incidence of Chromosomal Damage in Type 2 Diabetes Patients

In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c\<7.5%) and a high (HbA1c\>7.5%) glycemic group

The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.

University of Vienna

Director Research Platform Active Ageing

Diseases and Abnormalities at or Before Birth

Rare Diseases

Hyperandrogenism

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

Gastrointestinal Agents

Metformin

Pancrelipase

Pancreatin

All women will receive lifestyle management instructions at the baseline visit, before randomization.

Three treatment per week (4 weeks) and thereafter 2 times per week during 12 weeks.

Oral metformin 500 mg three times daily, in total 1500 mg per day.

All women will receive lifestyle management instructions at the baseline visit, before randomization. The lifestyle management involves one initial counselling session in connection with the baseline visit, which includes information about the importance of weight management, healthy diet and physical activity.

Lifestyle management

Disposable, single-use, sterilized CE marked needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50 mm will be inserted to a depth of 15-40 mm in segmental acupuncture points located in abdominal and leg muscles, with innervations corresponding to the ovaries and the pancreas. Two sets of acupuncture points will be alternated every second treatment.

Acupuncture

Oral metformin 500 mg three times daily, in total 1500 mg per day. To reduce gastrointestinal side-effects of metformin, the dose will be slowly escalated starting with 500 mg daily during the first week, increasing to 500 mg twice per day during the second the week, and 500 mg three times daily, morning, lunch and dinner from the third week in total 16 weeks including the 3 weeks step-up phase (i.e. 4 months).

Elisabet Stener-Victorin, PhD

Berit Legerstam, Study nurse

Jie Qiao, Professor

Haolin Zhang, PhD

Liselotte Blomberg, Study nurse

Angelica Linden-Hirschberg, Professor

Sebastian Gidlöf, PhD

The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and metformin), the investigators hypothesize that acupuncture is associated with less negative side-effects. The investigators also hypothesize that these treatments have the potential to restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and skeletal muscle tissue) and thus have the potential to prevent the development of type 2 diabetes (T2D).

Specific Aims The purpose of the study is to perform a randomized controlled trial of women with PCOS, comparing the effectiveness of lifestyle management alone, and in combination with acupuncture or metformin treatment on whole body glucose homeostasis, with the ultimate goal to prevent the development of type 2 diabetes.

Primary aim

1. To determine the clinical effectiveness of 4 months of 1) electroacupuncture + lifestyle management and 2) metformin + lifestyle management, compared to 3) lifestyle management only, for improvement of insulin sensitivity as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).

Secondary aims

1. To evaluate changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution.
2. To determine changes in genome-wide gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood.
3. To evaluate endocrine measures including menstrual pattern and ovulation frequency, circulating hormones (sex steroids, AMH, gonadotropins), and excretion of metabolites of sex steroids in urine.
4. To determine changes in women's HRQoL, symptoms of anxiety and depression, dieting and eating patterns, and negative side-effects.
5. To evaluate the cost-effectiveness of the different treatments.

Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial

Changes from baseline to after 4 months of treatment in HOMA-IR \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5) between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.

Changes from baseline to after 4 months of treatment in HbA1c between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.

Changes from baseline to after 4 months of treatment in insulin response to glucose during the OGTT (AUC using the trapezoidal rule) between 1) acupuncture + lifestyle management and 2) metformin + lifestyle management compared to 3) lifestyle management only.

Changes in secondary metabolic measures with calculation of e.g. HOMA-B

Changes in mRNA gene expression and DNA methylation expression and biomarkers in whole blood.

Changes in circulating circulating reproductive hormones.

Changes in women's HRQoL measured with polycystic ovary syndrome questionnaire (PCOSQ) and short form-36 (SF36) two validated questionnairs.

Changes in women's symptoms of anxiety and depression measured with the self-reported version of the Comprehensive Psychopathological Rating Scale for Affective Syndromes (CPRS-S-A).

Changes in women's dieting and eating patterns assessed with Three-Factor Eating Questionnaire (TFEQ-R21), and Questionnaire of Eating and Weight Patterns-Revised (QEWP-R).

Cost-effectiveness of the different treatments by calculation of e.g. treatment visits, time for patient and with EuroQol-5 dimension (EQ-5D).

Karolinska University Hospital

Peking University

Karolinska Institutet

PhD, Associate Professor

Body Weight

Weight Gain

Body Weight Changes

Empagliflozin

Sodium-Glucose Transporter 2 Inhibitors

Each participant will receive empagliflozin 10mg daily for 3 months

Each participant will receive metformin 1000mg daily for 3 months

Each participant will receive empagliflozin 10mg daily for 3 months.

Empagliflozin 10 MG

Each participant will receive metformin 1000mg daily for 3 months.

MetFORMIN 500 Mg Oral Tablet

Hina Sharif, PharmD,MSPH

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.

This study for women of reproductive age only

Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily.

assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevalence of HbA1C in Women With PCOS	NCT01838122	Polycystic Ovar... Pelvic Endometr... Insulin Resista... Non-insulin Dep... Tubal Obstructi...		15 Years - 40 Years	Southern Cross Fertility Centre
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)	NCT02231736	Type 2 Diabetes Cancer		30 Years -	University of Vienna
Acupuncture or Metformin for Insulin Resistance in Women With PCOS	NCT02647827	Polycystic Ovar... Insulin Resista... Hyperandrogenis...	Lifestyle manag... Acupuncture Metformin	18 Years - 40 Years	Karolinska Institutet
Prevalence of HbA1C in Women With PCOS	NCT01838122	Polycystic Ovar... Pelvic Endometr... Insulin Resista... Non-insulin Dep... Tubal Obstructi...		15 Years - 40 Years	Southern Cross Fertility Centre
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)	NCT02231736	Type 2 Diabetes Cancer		30 Years -	University of Vienna
Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity	NCT06140108	Polycystic Ovar... Weight Gain HbA1c	Empagliflozin 1... MetFORMIN 500 M...	15 Years - 49 Years	SINA Health Education and Welfare Trust

Spots Global Cancer Trial Database for hba1c

Every month we try and update this database with for hba1c cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hba1c

Every month we try and update this database with for hba1c cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hba1c cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.