Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity

Trial Title: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity

NCT ID: NCT06325449

Condition: Polycystic Ovary Syndrome
Obesity

Conditions: Official terms:
Polycystic Ovary Syndrome
Obesity
Body Weight

Conditions: Keywords:
Polycystic Ovary Syndrome
Obesity
Endocrine
Noncommunicable Diseases
Surveys and Questionnaires
Metabolic Disease
Insulin Sensitivity

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: STREAM program
Description: The STREAM program is a 24-week weight-loss program which includes meal replacement, dietician coaching/teaching and weekly visits with a physician.
Arm group label: STREAM Weight-loss Program

Summary: The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much? Participants will complete a 24-week weight loss program (STREAM). During this program they will: - weigh themselves - complete regular bloodwork and - fill out a Quality of Life questionnaire at regular intervals

Detailed description: Polycystic ovary syndrome is a common disorder affecting up to 20% of women of reproductive age associated with, but not exclusive to, obesity. Excess weight and especially visceral adiposity lead to increased insulin resistance which in turn will promote decreased SHBG concentrations and excess androgen secretion from the ovaries. Weight-loss is known to improve PCOS symptoms in individuals but threshold of weight-loss needed to achieve improvement in many PCOS outcomes is poorly understood, as is the impact of varied weight-loss strategies employed to promote weight loss. OBJECTIVE The goal of this study is to understand the effects of increasing weight loss thresholds on multiple PCOS symptoms and features, using a 24-week intensive weight loss program (STREAM) with the possibility of added pharmacotherapy for weight loss when indicated. RESEARCH QUESTION What is the required weight loss to achieve significant improvement in PCOS outcomes including metabolic, endocrine, fertility and mental health parameters? Is there a difference in outcome improvement from different approaches (meal replacement, adjunct pharmacotherapy), independent from weight-loss? PRIMARY OUTCOMES To identify the percentage of bodyweight loss needed to achieve significant improvement in each of the following: - Endocrine parameters (SHBG, Testosterone, Androstenedione, LH/FSH ratio) - Insulin sensitivity (HOMA-IR) - Lipid profile (TG, HDL and Non-HDL levels) - Liver enzyme profile (ALT) - Menstrual cyclicity (yes/no) - Quality of life scale (QOLS-public domain, see annex) STUDY DESIGN Participants will be recruited from those already referred to the LEAF Clinic. Women over the age of 18 who meet the inclusion criteria will be invited to participate in the STREAM program, a 24-week intensive weight-loss program that includes full and partial meal replacement, dietician group coaching and weekly meetings with a weight-loss specialist physician. The program cost, $2250, will be waived for the purpose of limiting sampling bias as the cost can be untenable for many patients. DATA COLLECTION Participants will complete PCOS-specific blood tests at the launch of the program, at the end of the 24 weeks and then again at 6 months after the program is finished. They will also be asked to complete the same blood draws at every 5% weight loss from their baseline. Participants will also be asked to complete the Quality of Life Scale (QOLS), a short survey, at the same intervals. ANTICIPATED RESULTS Learning more about individual variations in outcome improvement with gradual weight loss in a population of women living with PCOS will be helpful in individualizing approaches to weight loss in this population. This study could not only help determine predictors of improvement for each outcome but as well identify weight loss strategies that are more efficient for specific outcomes. This will result in better care for women living with PCOS.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Pre-menopausal female ≥ 18 years old - BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with adiposity-related complications - English proficiency - Referral to LEAF Weight Management Clinic Exclusion Criteria: - Previous bariatric surgery - Currently on OCP or using an IUD - Currently using a pharmacotherapy with an impact on weight (Liraglutide, Semaglutide, Tirzepatide, Naltrexone/Buproprion, Orlistat) - Currently pregnant - Currently using an androgen supplement (Testosterone, DHEAS)

Gender: Female

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: LEAF Weight Management Clinic

Address:
City: Ottawa
Zip: K1J9L3
Country: Canada

Contact:
Last name: Judy Shiau, MD

Phone: 613-701-1222
Email: dr.shiau@leafwmc.ca

Contact backup:
Last name: Julie Laroche

Phone: 613-701-1222
Email: info@leafwmc.ca

Start date: April 1, 2024

Completion date: January 1, 2026

Lead sponsor:
Agency: Ottawa Hospital Research Institute
Agency class: Other

Collaborator:
Agency: LEAF Weight Loss Clinic
Agency class: Other

Source: Ottawa Hospital Research Institute

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

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06325449