Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Alberta
About this trial
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.
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Eligibility criteria
Qualifiers
Age 12-18 years
BMI percentile > 95% for age/sex;
Total weight fluctuation over past 6 months < 10%;
HOMA-IR > 3.16;
Disqualifiers
Current use of insulin or diagnosis of T2DM;
Systolic or diastolic blood pressure (BP) > 99th percentile for age and sex;
Acute infectious or inflammatory condition over the preceding 1 month; hospitalization > 48 hrs;
History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders;
Trial design
Treatments tested in this trial
- Metformin 850 mg oral tablet bid
- Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov