Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Recruiting
Phase 3
Interventional Study
Obesity, Childhood
Insulin Resistance
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- University of Alberta · Other
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About This Trial
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 chang…
Trial Locations
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Eligibility 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 blo…
Contacts