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Taking people in CanadaPhase 3

Fiber and metformin tested together in teens with obesity and insulin resistance

Tests fiber, metformin, and both together in teenagers with severe obesity.

Key facts

Who runs it
University of Alberta
Where
Edmonton, CanadaSee the site
Trial code
Registry title
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Status
Recruiting
Phase
Phase 3
People taking part
90 people, planned
Started
22 Oct 2021
Expected to end
Feb 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 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.
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for teenagers aged 12 to 18 with severe obesity, insulin resistance and a family history of type 2 diabetes.

Age
12 to 18 years
Sex
Boys and girls can both join.
Disease stage
BMI percentile above 95% for age and sex. HOMA-IR above 3.16.
Earlier treatment
No antibiotics in the past 60 days. No probiotic or prebiotic supplements in the past 30 days. No lipid-lowering or anti-inflammatory medicine. No weight-affecting medicine in the past year.
Biomarker or test result
HOMA-IR above 3.16. A first- or second-degree relative with type 2 diabetes.

Main reasons for not taking part

  • Uses insulin or has type 2 diabetes
  • Blood pressure above the 99th percentile for age and sex
  • Chronic disease such as inflammatory bowel disease, severe liver or kidney disease, or a neurologic disorder
  • Active cancer
  • Weight change of 10% or more in the past 6 months

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 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
  • Systolic or diastolic blood pressure (BP) > 99th percentile for age and sex
  • Current use of insulin or diagnosis of T2DM

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 18 years old?

Where in Canada

  • University of AlbertaEdmonton, CanadaContact: Andrea M Haqq, MD, MHSTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

.

The 3 groups in the trial

  • METExisting treatment, for comparison

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

    Treatment: Metformin 850 mg oral tablet bid

  • FIBERExisting treatment, for comparison

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

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

  • FIBER + METTreatment being tested

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

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
Plain-language title
Fiber and metformin tested together in teens with obesity and insulin resistanceGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04578652, who can take part
Publications
Record updated
23 October 2026