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

Obesity Clinical Trial

— FLOWERS-PCOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325449
• Other study ID #: 5323
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Ottawa Hospital Research Institute
• Contact: Judy Shiau, MD
• Phone: 613-701-1222
• Email: dr.shiau[@]leafwm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	LEAF Weight Management Clinic	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	LEAF Weight Loss Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	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.
Primary	Change in Endocrine parameters (EP) as measure by blood test	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.
Primary	Change in insulin sensitivity (IS) as measure by blood test	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.
Primary	Change in Lipid profile (LP) as measure by blood test	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.
Primary	Change in liver enzyme profile (LEP) as measure by blood test	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.
Primary	Change in Menstrual Cyclicity	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.
Primary	Quality of Life (QoL) Scale	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