Combining fiber and metformin to treat obesity and insulin resistance in teens
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
This study is testing whether adding fiber to the diabetes drug metformin can help teens aged 12-18 with severe obesity and insulin resistance improve their health over a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04578652 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dietary fiber and metformin, both separately and in combination, on adolescents aged 12-18 with severe obesity and insulin resistance over a 12-month period. The study employs a double-blind, randomized, three-arm parallel design to assess changes in glucose metabolism, inflammation, and body mass index (BMI). Additionally, it aims to explore how these interventions may influence gut microbiome composition and function. The hypothesis is that the combination of fiber and metformin will yield greater improvements in metabolic function compared to either treatment alone.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 with a BMI above the 95th percentile and a family history of type 2 diabetes.
Not a fit: Patients currently using insulin or diagnosed with type 2 diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve metabolic health and weight management in adolescents with obesity and insulin resistance.
How similar studies have performed: Previous studies have shown positive outcomes with similar dietary and pharmacological interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 12-18 years 2. BMI percentile \> 95% for age/sex; 3. Total weight fluctuation over past 6 months \< 10%; 4. HOMA-IR \> 3.16; 5. FH of T2DM (first or second-degree relative). Exclusion Criteria: 1. Current use of insulin or diagnosis of T2DM; 2. Systolic or diastolic blood pressure (BP) \> 99th percentile for age and sex; 3. Acute infectious or inflammatory condition over the preceding 1 month; hospitalization \> 48 hrs; 4. History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders; 5. Active malignancy; 6. Concomitant use of medication/investigational drug known to affect body weight in the past year; 7. Antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in the past 30 days; use of lipid-lowering and anti-inflammatory medication.
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Andrea M Haqq, MD, MHS — University of Alberta
- Study coordinator: Andrea M Haqq, MD, MHS
- Email: haqq@ualberta.ca
- Phone: 780-492-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.