NCT04578652RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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. .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 1 Sept 2020
- Start date
- 22 Oct 2021
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- University of Alberta
- Diseases
- Obesity
- NCT number
- NCT04578652
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 90
- From 22 Oct 2021 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Age
- Systolic or diastolic blood pressure (BP) \> 99th percentile for age and sex;
Other
- Current use of insulin or diagnosis of T2DM;
Who the study is looking for
- 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).
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.