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

Insulin Resistance Clinical Trial

Official title:
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.

Clinical Trial 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. .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04578652
Study type Interventional
Source University of Alberta
Contact Andrea M Haqq, MD, MHS
Phone 780-492-0015
Email haqq@ualberta.ca
Status Recruiting
Phase Phase 3
Start date October 22, 2021
Completion date September 2025
View Details
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