Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325449
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-11-20
Brief Title:
Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOWERS-PCOS
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
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 LHFSH ratio
Insulin sensitivity HOMA-IR
Lipid profile TG HDL and Non-HDL levels
Liver enzyme profile ALT
Menstrual cyclicity yesno
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
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 LHFSH ratio
Insulin sensitivity HOMA-IR
Lipid profile TG HDL and Non-HDL levels
Liver enzyme profile ALT
Menstrual cyclicity yesno
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None