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

March 15, 2024 updated by: Ottawa Hospital Research Institute

Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity - A Prospective Study Using a Multi-disciplinary Multi-modal Approach to Weight-loss

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lesley Ananny, BA
  • Phone Number: 613-701-1222
  • Email: lananny@ohri.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1J9L3
        • LEAF Weight Management Clinic
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Weight will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be done a pre-determined time as weight loss isn't linear/predictable.
percentage difference in participant weight
Weight will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be done a pre-determined time as weight loss isn't linear/predictable.
Change in Endocrine parameters (EP) as measure by blood test
Time Frame: EP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in blood test results (SHBG, Testosterone, Androstenedione, LH/FSH ratio) which are all endocrine markers of PCOS
EP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in insulin sensitivity (IS) as measure by blood test
Time Frame: IS will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in blood test results (HOMA-IR) which is a marker of PCOS
IS will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in Lipid profile (LP) as measure by blood test
Time Frame: LP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in blood test results (TG, HDL and Non-HDL levels) which are markers of PCOS
LP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in liver enzyme profile (LEP) as measure by blood test
Time Frame: LEP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in blood test results (ALT) which is a marker of PCOS
LEP will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (5%), a measurement which cannot be scheduled pre-determined as weight loss isn't predictable.
Change in Menstrual Cyclicity
Time Frame: Patients will be asked to report on their menstrual cycles at the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every 5% weightloss milestone, which cannot be scheduled in advance as it isn't predictable/linear.
Regularity of menstrual cycles
Patients will be asked to report on their menstrual cycles at the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every 5% weightloss milestone, which cannot be scheduled in advance as it isn't predictable/linear.
Quality of Life (QoL) Scale
Time Frame: QoLs will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (every 5%) which cannot be done at a predetermined time as weight loss isn't predictable or linear
QoLs is a public-domain questionnaire measuring several subjective quality-of-life parameters
QoLs will be compared from the beginning of the program, at the end (24 weeks), six months later (52 weeks) and at every major weight loss milestone (every 5%) which cannot be done at a predetermined time as weight loss isn't predictable or linear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

LEAF Weight Loss Clinic

Investigators

  • Principal Investigator: Judy Shiau, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD with other researchers at this time and we are not seeking permission to do so from our research ethics board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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