Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Diabetes Mellitus

Syndrome

Overweight

Obesity

Body Weight

Weight Gain

Diabetes, Gestational

Polycystic Ovary Syndrome

Gestational Weight Gain

Overnutrition

Nutrition 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

Metabolic Diseases

Glucose Metabolism Disorders

Intervention group: Intensive lifestyle intervention will be initiated from the first trimester (8-12wks) to delivery, with follow up every 2-4 weeks. Participants in the intervention group will be provided with an individualized dietary protocol with not less than 1500 calories per day in the first trimester and not less than 1800 calories per day after 13 weeks of gestation. Guidance on regular exercise is reinforced at the first and each follow up visit.

Standard care group: Participants will receive a 1.5-hour group session in which standard prenatal intervention on diet, nutrition and physical activity and recommendation for gestational weight gain are reviewed by a registered dietitian. Thereafter, participants will receive their regularly scheduled follow up visits without additional lifestyle guidance.

Dietary intervention combined with healthy lifestyle counseling

Intensive Lifestyle Intervention

Standard prenatal care on diet, nutrition and physical activity

Standard Care

Guanghui Li, MD, PhD

Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM.

Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.

Lifestyle Intervention in Pregnant Women With PCOS

Intensive Lifestyle Intervention on Gestational Weight Gain and Development of Gestational Diabetes Mellitus in Overweight/Obese Pregnant Women With a History of Polycystic Ovarian Syndrome

Capital Medical University

Associate Professor

Diseases and Abnormalities at or Before Birth

Glucose Intolerance

Congenital Abnormalities

Hypoglycemic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Arrhythmia Agents

Cardiotonic Agents

Metformin

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Acarbose

Glucagon

Cardiac Glycosides

Glycoside Hydrolase Inhibitors

Enzyme Inhibitors

3 months intensive lifestyle intervention, including low GI diet and exercise.

3 months GLP-1 Receptor Agonists treatment

intensive lifestyle intervention

Use GLP-1 Receptor Agonists 3 months to treat PCOS

GLP-1 Receptor Agonists

Tao Tao, MD

Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

We designed a non randomized control study to compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria. Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\> 11%, triglycerides \>600 mg/dl).

Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.

We will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment

RenJi Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lifestyle Intervention in Pregnant Women With PCOS	NCT04216485	Polycystic Ovar... Overweight and ... Gestational Dia...	Intensive Lifes... Standard Care	18 Years - 45 Years	Capital Medical University
Research of Intensive Lifestyle Intervention for PCOS Patients With IGT	NCT02446834	Polycystic Ovar...	intensive lifes... GLP-1 Receptor ... Metformin Acarbose	14 Years - 50 Years	RenJi Hospital

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