Combining fiber and metformin to treat obesity and insulin resistance in teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.