NCT04578652 Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
| NCT ID | NCT04578652 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alberta |
| Condition | Obesity, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-10-22 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2021-10-22 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. .
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 blood pressure (BP) \> 99th percentile for age and sex; 3. Acute infectious or inflammatory condition over the preceding 1 month; hospitalization \> 48 hrs; 4. History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders; 5. Active malignancy; 6. Concomitant use of medication/investigational drug known to affect body weight in the past year; 7. 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.
Contact & Investigator
Andrea M Haqq, MD, MHS
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT04578652 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Obesity, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04578652 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT04578652 currently recruiting?
Yes, NCT04578652 is actively recruiting participants. Contact the research team at haqq@ualberta.ca for enrollment information.
Where is the NCT04578652 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04578652 clinical trial?
NCT04578652 is sponsored by University of Alberta. The principal investigator is Andrea M Haqq, MD, MHS at University of Alberta. The trial plans to enroll 90 participants.
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