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

Who is this study for? Adolescents with severe obesity and insulin resistance
What treatments are being studied? Metformin+Supplemental fiber mixture
Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 12-18 years

• BMI percentile \> 95% for age/sex;

• Total weight fluctuation over past 6 months \< 10%;

• HOMA-IR \> 3.16;

• FH of T2DM (first or second-degree relative).

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Andrea M Haqq, MD, MHS
haqq@ualberta.ca
780-492-0015
Time Frame
Start Date: 2021-10-22
Estimated Completion Date: 2025-09
Participants
Target number of participants: 90
Treatments
Active_comparator: MET
MET (850 mg po bid - standard of care) + Fiber placebo daily
Active_comparator: FIBER
Fiber supplementation \[35g fiber daily\] + MET placebo po bid
Experimental: FIBER + MET
Fiber supplementation \[35g fiber daily\] + MET 850 mg po bid
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov