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

NCT ID: NCT06325449

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-01-01

Brief 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.

Conditions

Polycystic Ovary Syndrome; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STREAM Weight-loss Program

All patients who participate in the study will be recruited to the Intervention Arm and will undergo the STREAM program, a 24-week weight loss program which includes meal replacement, dietician teaching and regular appointments with their bariatric medicine specialist.

Group Type: EXPERIMENTAL

STREAM program

Intervention Type: BEHAVIORAL

The STREAM program is a 24-week weight-loss program which includes meal replacement, dietician coaching/teaching and weekly visits with a physician.

Interventions

STREAM program

The STREAM program is a 24-week weight-loss program which includes meal replacement, dietician coaching/teaching and weekly visits with a physician.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LEAF Weight Loss Clinic

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Shiau, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

LEAF Weight Management Clinic

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Judy Shiau, MD

Role: CONTACT

dr.shiau@leafwm.com

613-701-1222

Lesley Ananny, BA

Role: CONTACT

lananny@ohri.ca

613-701-1222

Facility Contacts

Judy Shiau, MD

Role: primary

dr.shiau@leafwmc.ca

613-701-1222

Julie Laroche

Role: backup

info@leafwmc.ca

613-701-1222

Other Identifiers

5323

Identifier Type: -

Identifier Source: org_study_id