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NCT Number: NCT04578652

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

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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Key information

Conditions

Obesity, Childhood Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location status: Recruiting

Location contact

Andrea M Haqq, MD, MHS

CONTACT

[email protected]

780-492-0015

Andrea M Haqq, MD, MHS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 liver or kidney disease or neurologic disorders;
  • Active malignancy;
  • Concomitant use of medication/investigational drug known to affect body weight in the past year;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in HOMA-IR

    Time frame: Baseline, 6, and 12 months

    Change in HOMA-IR value

Secondary outcomes

  1. Changes in body weight

    Time frame: Baseline, 6, and 12 months

    Body weight measured in kg

  2. Changes in body mass index (BMI)

    Time frame: Baseline, 6, and 12 months

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

  3. Changes in body composition

    Time frame: Baseline, 6, and 12 months

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

  4. Changes in inflammation

    Time frame: Baseline, 6, and 12 months

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

  5. Changes in metabolic function

    Time frame: Baseline, 6, and 12 months

    The markers of metabolic function that will be measured are: fasting glucose, lipids (total, high and low density lipoprotein cholesterol; triglycerides), and oral glucose tolerance test.

  6. Changes in satiety hormones

    Time frame: Baseline, 6, and 12 months

    Markers of satiety that will be measured are: acylated ghrelin, peptide tyrosine tyrosine, GLP-1, leptin, and adiponectin.

  7. Changes in quality of life

    Time frame: Baseline, 6, and 12 months

    Quality of life will be measured by the a questionnaire

  8. Changes in perceived hunger and satiety

    Time frame: Baseline, 6, and 12 months

    Perceived hunger and satiety will be assessed by a questionnaire

  9. Changes in gut microbiota composition

    Time frame: Baseline, 6, and 12 months

    Fecal microbiota composition will be characterized by 16S rRNA gene amplicons sequencing using taxonomic and non-taxonomic based approaches.

  10. Changes in gut microbiome functions

    Time frame: Baseline, 6, and 12 months

    Fecal microbiome functions will be assessed through whole metagenomic sequencing, stool SCFAs and bile acids, and plasma metabolomics.

  11. Changes in intestinal barrier integrity

    Time frame: Baseline, 6, and 12 months

    Plasma lipopolysaccharide-binding protein and fecal calprotectin will be determined as measures of gut barrier integrity

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea M Haqq, MD, MHS

CONTACT

[email protected]

780-492-0015

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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