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Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 17, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Sep 2025 to Sep 2026v7
  2. 3 versions Re-verified since Apr 3, 2023, no change to tracked fieldsv4-v6
  3. Start date changed from estimate of Jan 2022 to Oct 22, 2021v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2020 to Jan 2022
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Alberta
248 trials monitored
See 16 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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. .
Trial Details
NCT Number NCT04578652
Lead Sponsor University of Alberta
Conditions
(from sponsor)		 Obesity, Childhood, Insulin Resistance
Related terms Insulin Resistance, Pediatric Obesity
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov