Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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.
.