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

NCT06325449 | Not Yet Recruiting

• 1 other identifier: 5323
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Ovary Syndrome; Obesity

Keywords

Polycystic Ovary Syndrome; Obesity; Endocrine; Noncommunicable Diseases; Surveys and Questionnaires; Metabolic Disease; Insulin Sensitivity

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

Study Arms (1)

STREAM Weight-loss Program

EXPERIMENTAL

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

Interventions

STREAM program BEHAVIORAL

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

STREAM Weight-loss Program

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• LEAF Weight Loss Clinic: collaborator

Study Sites (1)

LEAF Weight Management Clinic

Ottawa, Ontario, K1J9L3, Canada

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Noncommunicable Diseases; Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Judy Shiau, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Shiau, MD

CONTACT

613-701-1222; dr.shiau@leafwm.com

Lesley Ananny, BA

CONTACT

613-701-1222; lananny@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)