Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome

Trial Title: Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome

NCT ID: NCT06545721

Condition: Polycystic Ovary Syndrome

Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Weight Cycling

Conditions: Keywords:
Weight Cycling
Hyperandrogenemia
Insulin Resistance
High-protein diet
Transcriptome
Metabolome
Inflammatory status

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: the sample size for the normal weight group is 45, and the sample size for the overweight/obese group is 380.

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Adjusting dietary structure + exercise + behavioral intervention
Description: Adjusting to a healthy diet involves consuming low GI and low-fat foods, avoiding sugary drinks, increasing dietary fiber intake, reducing saturated fat while increasing omega-3 unsaturated fat intake, and limiting trans fat consumption. A weight loss program includes a high-protein diet, exercise, and behavioral intervention with daily total energy needs calculated based on ideal body weight (kg) x 15-20 kcal/kg/d; developing a daily meal plan with regular protein supplementation; limiting salt intake to ≤5 g/d; ensuring adequate water consumption at 2-3L/d; aiming for a dietary fiber intake of 25-30g/d; recommending micronutrient supplementation as needed; maintaining daily aerobic exercise (40 minutes at 70-80% HRmax) along with resistance training (20 minutes); establishing an early bedtime before 11pm and an early wake-up time.
Arm group label: Normal weight group
Arm group label: Obese/Overweight Group

Summary: This study prospectively includes PCOS patients with normal weight and overweight/obesity, closely follows up and intensively manages them, and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention (high-protein diet for weight loss). Additionally, it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction (<2% [equivalent to no weight loss], 2-5%, 5-10%, ≥10%) at different time points (3 months, 6 months) following dietary intervention. Furthermore, this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound, those who successfully lost weight, and those who experienced weight rebound. This will help explore the impact of weight cycling on PCOS-related manifestations. Finally, at a genetic level, the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics, transcriptomics, and metabolomics among patient groups.

Detailed description: This study is a single-center, prospective cohort study that enrolled PCOS patients after screening. The patients were categorized into two groups based on their BMI: a normal weight group (18.5 kg/m2 ≤ BMI < 24 kg/m2) with a sample size of 45 and an overweight/obese group (BMI ≥ 24 kg/m2) with a sample size of 380, totaling 425 cases. For the normal weight PCOS patients, interventions included control of total energy intake, adjustment of dietary structure, exercise, and behavioral intervention to prevent weight gain over a follow-up period of three months. If weight gain occurred during the follow-up period, these patients were transferred to the overweight/obese group for intensified intervention. The overweight/obese PCOS patients received intensive intervention in accordance with high-protein diet adaptation criteria. This involved high-protein diets combined with exercise and behavioral intervention for weight reduction. After three months of follow-up, if they achieved their weight-loss goal, they transitioned to a low-energy diet and exercise intervention program to maintain their weight. If the goal was not met after three months, they continued with the high-protein weight-loss program. The study compared differences in improvement in indicators such as insulin resistance (IR), blood androgen levels, inflammatory factors among different degrees of weight loss (<2%, 2% ≤weight loss <5%, 5%≤weight loss<10%, ≥10%), analyzing potential mechanisms. For individuals experiencing weight cycling, differences in IR levels before and after rebounding from body mass were compared alongside changes in androgen levels and other metabolic indicators. This aimed to explore the impact of body mass cycling on clinical indicators while analyzing potential causes.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Women aged 18-45 years in the reproductive period; 2. Women who have previously met the Rotterdam diagnostic criteria (at least 2 of the following 3 criteria have been confirmed, and have been diagnosed with PCOS): 1) Oligomenorrhea and/or anovulation; 2) clinical and/or biochemical evidence of hyperandrogenism; 3) ultrasound showing the presence of unilateral or bilateral polycystic ovaries; 3. Inclusion of 50 women in the normal weight group: 18.5 kg/m² ≤ BMI < 24 kg/m²; Inclusion of 400 women in the overweight/obese group: BMI ≥ 24 kg/m²; 4. Voluntarily participate in the intervention and sign an informed consent form. Exclusion Criteria: 1. Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy; 2. Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.); 3. History of weight loss surgery; 4. History of severe cardiovascular or cerebrovascular diseases; severe liver or kidney dysfunction (ALT > 3 times the upper limit of normal, or creatinine > 1.5 times the upper limit of normal); chronic or active gastrointestinal inflammatory diseases; severe systemic diseases; active malignant tumors; 5. Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.; 6. Known history of serious endocrine system diseases; 7. Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety/depression); 8. Unable to follow up on time or deemed non-cooperative by the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking Union Medical College Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Contact:
Last name: Wei Chen, PhD

Phone: 13911006820
Email: txchenwei@sina.com

Contact backup:
Last name: Menglu Zhang, PhD

Phone: 13051336015
Email: 499527281@qq.com

Start date: August 15, 2024

Completion date: August 15, 2026

Lead sponsor:
Agency: Peking Union Medical College Hospital
Agency class: Other

Source: Peking Union Medical College Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06545721