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

Phase

Condition

Obesity

Diabetes (Pediatric)

Diabetes And Hypertension

Treatment

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.

Clinical Study ID

NCT04578652

RN. # 414120

Ages 12-18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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).

Exclusion

Exclusion Criteria:

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 liveror kidney disease or neurologic disorders;
Active malignancy;
Concomitant use of medication/investigational drug known to affect body weight inthe past year;
Antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in thepast 30 days; use of lipid-lowering and anti-inflammatory medication.

Study Design