Weight Loss Program for PCOS and Obesity

(FLOWERS-PCOS Trial)

Overseen By Lesley Ananny, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: OCP, IUD, Weight drugs, Androgens

Disqualifiers: Bariatric surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that impact weight, such as Liraglutide, Semaglutide, Tirzepatide, Naltrexone/Buproprion, and Orlistat, as well as androgen supplements like Testosterone and DHEAS. If you are currently using these, you would need to stop before participating.

What data supports the effectiveness of the STREAM treatment for weight loss in women with PCOS and obesity?

Research shows that lifestyle changes, including diet and exercise, can help women with PCOS lose weight, which can improve symptoms. Although specific data on the STREAM program isn't available, similar approaches have shown weight loss of up to 10% of body weight, which can significantly reduce PCOS symptoms. ^{1 2 3 4 5}

Is the STREAM program safe for humans?

The STREAM program, which may involve treatments like liraglutide and semaglutide, has shown to be generally safe in humans with very few side effects reported in studies. These treatments have been used in people with obesity and PCOS, and have shown positive effects on weight loss and metabolic health. ^{6 7 8 9 10}

How does the STREAM treatment for weight loss in PCOS and obesity differ from other treatments?

The STREAM treatment is unique because it involves a medically supervised fitness program that combines nutrition and exercise, specifically designed for women with PCOS who are overweight or obese. This approach focuses on lifestyle changes rather than medication, aiming for sustainable weight loss and improvement in PCOS symptoms. ^{1 6 11 12 13}

What is the purpose of this trial?

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

Research Team

Judy Shiau, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for females with obesity and Polycystic Ovary Syndrome (PCOS). Participants will engage in a 24-week intensive weight loss program called STREAM. They'll track their weight, undergo bloodwork, and fill out quality of life questionnaires regularly.

Inclusion Criteria

English proficiency

I have been referred to the LEAF Weight Management Clinic.

My BMI is 30 or higher, or it's 27 or higher with weight-related health issues.

Exclusion Criteria

Currently pregnant

I have had weight loss surgery in the past.

Currently on OCP or using an IUD

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-week intensive weight loss program (STREAM) including meal replacement, dietician group coaching, and weekly meetings with a weight-loss specialist physician.

24 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood tests and quality of life assessments at 6 months post-treatment.

28 weeks

2 visits (in-person)

Treatment Details

Interventions

• STREAM program

Trial Overview The STREAM program's effectiveness on weight loss and health improvements in PCOS patients is being tested. The study focuses on how much weight participants lose and the changes in health markers like insulin sensitivity over the course of the program.

Participant Groups

Group I: STREAM Weight-loss Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

LEAF Weight Loss Clinic

Collaborator

Trials

2

Recruited

80+

Findings from Research

In a study of 27 obese patients with PCOS who did not respond to lifestyle modifications, treatment with semaglutide led to an average weight loss of 7.6 kg after three months, with 80% of participants achieving at least a 5% reduction in body weight.

Semaglutide treatment not only resulted in significant weight loss but also improved insulin sensitivity and normalized menstrual cycles in 80% of responsive patients, all with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Treatment of Excessive Body Weight in Obese PCOS Patients Unresponsive to Lifestyle Programs. Carmina, E., Longo, RA.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

Implementing the international evidence-based guideline of assessment and management of polycystic ovary syndrome (PCOS): how to achieve weight loss in overweight and obese women with PCOS? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Weight loss intervention for obese older women: improvements in performance and function. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Effects of three treatment modalities (diet, myoinositol or myoinositol associated with D-chiro-inositol) on clinical and body composition outcomes in women with polycystic ovary syndrome. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effective treatment of polycystic ovarian syndrome with Roux-en-Y gastric bypass. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of obesity in polycystic ovary syndrome: a position statement of the Androgen Excess and Polycystic Ovary Syndrome Society. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Obesity and polycystic ovary syndrome. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome. [2020]

8. Italy pubmed.ncbi.nlm.nih.gov

Short-time effects of ketogenic diet or modestly hypocaloric Mediterranean diet on overweight and obese women with polycystic ovary syndrome. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Semaglutide Treatment of Excessive Body Weight in Obese PCOS Patients Unresponsive to Lifestyle Programs. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Weight control and its beneficial effect on fertility in women with obesity and polycystic ovary syndrome. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Supervised short-term nutrition and exercise promotes weight loss in overweight and obese patients with polycystic ovary syndrome. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Overweight in polycystic ovary syndrome. An update on evidence based advice on diet, exercise and metformin use for weight loss. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial. [2021]