Clinical trial NCT06325449: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Keywords: Polycystic Ovary Syndrome
Obesity
Endocrine
Noncommunicable Diseases
Surveys and Questionnaires
Metabolic Disease
Insulin Sensitivity
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: LEAF Weight Loss Clinic
First posted: 2024-03-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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:

* 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Weight loss
timeFrame: 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.
measure: Change in Endocrine parameters (EP) as measure by blood test
timeFrame: 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.
measure: Change in insulin sensitivity (IS) as measure by blood test
timeFrame: 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.
measure: Change in Lipid profile (LP) as measure by blood test
timeFrame: 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.
measure: Change in liver enzyme profile (LEP) as measure by blood test
timeFrame: 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.
measure: Change in Menstrual Cyclicity
timeFrame: 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.
measure: Quality of Life (QoL) Scale
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: LEAF Weight Management Clinic
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Judy Shiau, MD
role: PRINCIPAL_INVESTIGATOR
References: