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

ConditionsObesity, ChildhoodInsulin 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metformin 850 mg oral tablet bid

    Drug

    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).

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

    Dietary supplement

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: METActive comparator 1 intervention
Group B: FIBERActive comparator 1 intervention
Group C: FIBER + METExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes in HOMA-IR

Change in HOMA-IR value

Time frame
Baseline, 6, and 12 months

Secondary outcomes

1

Changes in body weight

Body weight measured in kg

Time frame
Baseline, 6, and 12 months
2

Changes in body mass index (BMI)

BMI percentile and z-score according to age and sex will be estimated

Time frame
Baseline, 6, and 12 months
3

Changes in body composition

Body density using air-displacement plethysmography will be assessed to estimate fat mass and fat-free mass.

Time frame
Baseline, 6, and 12 months
4

Changes in inflammation

Markers of inflammation that will be measured are: high-sensitivity C-reactive protein, interleukin, tumor necrosis factor-alpha)

Time frame
Baseline, 6, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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