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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Endocrine parameters (EP) as measure by blood test
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: STREAM program (Behavioral)
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported