Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Key facts
- Where
- Edmonton, CanadaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Where in Canada
- University of AlbertaEdmonton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alberta
- Trial code
- NCT04578652
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
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.
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Inclusion: Age 12-18 years; BMI percentile > 95% for age/sex; Total weight fluctuation over past 6 months < 10%; HOMA-IR > 3.16; FH of T2DM (first or second-degree relative).
Exclusion: Concomitant use of medication/investigational drug known to affect body weight in the past year; 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; Acute infectious or inflammatory condition over the preceding 1 month; hospitalization > 48 hrs; History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders; Active malignancy; Systolic or diastolic blood pressure (BP) > 99th percentile for age and sex; Current use of insulin or diagnosis of T2DM.