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

PHASE3RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 22, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Obesity, ChildhoodInsulin Resistance
Interventions
DRUG

Metformin 850 mg oral tablet bid

MET dose: 500 mg daily, increasing to 500 bid if tolerated after 2 weeks, then increasing again 2 weeks later to 850 mg bid (1700 mg daily).

DIETARY_SUPPLEMENT

Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.

The first week of treatment will use 1/3 the daily treatment dose; then 2/3 dose for the second and third weeks; then the full dose thereafter, to allow time for adaptation.

Trial Locations (1)

T6G 2E1

RECRUITING

University of Alberta, Edmonton

All Listed Sponsors
lead

University of Alberta

OTHER