Actively Recruiting
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Led by University of Alberta · Updated on 2025-11-17
90
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance \[IR\]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM. .
CONDITIONS
Official Title
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to 18 years
- BMI percentile greater than 95% for age and sex
- Total weight change less than 10% over the past 6 months
- HOMA-IR greater than 3.16 indicating insulin resistance
- Family history of type 2 diabetes in a first or second-degree relative
You will not qualify if you...
- Current use of insulin or diagnosis of type 2 diabetes
- Blood pressure above the 99th percentile for age and sex
- Acute infection or inflammation in the past month or hospitalization over 48 hours
- History of chronic diseases like inflammatory bowel disease, severe liver or kidney disease, or neurological disorders
- Active cancer
- Use of weight-affecting medications or investigational drugs in the past year
- Use of antibiotics in the past 60 days
- Use of probiotic or prebiotic supplements in the past 30 days
- Use of lipid-lowering or anti-inflammatory medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Actively Recruiting
Research Team
A
Andrea M Haqq, MD, MHS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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