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

University of Alberta

Status and phase: Enrolling; Phase 3

Conditions: Obesity, Childhood; Insulin Resistance

Treatments: Dietary Supplement: Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.; Drug: Metformin 850 mg oral tablet bid

Study type: Interventional

Funder types: Other

Identifiers

NCT04578652

RN. # 414120

Details and patient eligibility

About

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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Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 12-18 years
2. BMI percentile > 95% for age/sex;
3. Total weight fluctuation over past 6 months < 10%;
4. HOMA-IR > 3.16;
5. FH of T2DM (first or second-degree relative).

Exclusion criteria

1. Current use of insulin or diagnosis of T2DM;
2. Systolic or diastolic blood pressure (BP) > 99th percentile for age and sex;
3. Acute infectious or inflammatory condition over the preceding 1 month; hospitalization > 48 hrs;
4. History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders;
5. Active malignancy;
6. Concomitant use of medication/investigational drug known to affect body weight in the past year;
7. Antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in the past 30 days; use of lipid-lowering and anti-inflammatory medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

MET

Active Comparator group

Description:

MET (850 mg po bid - standard of care) + Fiber placebo daily

Treatment:

Drug: Metformin 850 mg oral tablet bid

FIBER

Active Comparator group

Description:

Fiber supplementation \[35g fiber daily\] + MET placebo po bid

Treatment:

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

FIBER + MET

Experimental group

Description:

Fiber supplementation \[35g fiber daily\] + MET 850 mg po bid

Treatment:

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

Drug: Metformin 850 mg oral tablet bid