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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04578652
Other study ID # RN. # 414120
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 22, 2021
Est. completion date September 2025

Study information

Verified date April 2024
Source University of Alberta
Contact Andrea M Haqq, MD, MHS
Phone 780-492-0015
Email haqq@ualberta.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. .


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in HOMA-IR Change in HOMA-IR value Baseline, 6, and 12 months
Secondary Changes in body weight Body weight measured in kg Baseline, 6, and 12 months
Secondary Changes in body mass index (BMI) BMI percentile and z-score according to age and sex will be estimated Baseline, 6, and 12 months
Secondary Changes in body composition Body density using air-displacement plethysmography will be assessed to estimate fat mass and fat-free mass. Baseline, 6, and 12 months
Secondary Changes in inflammation Markers of inflammation that will be measured are: high-sensitivity C-reactive protein, interleukin, tumor necrosis factor-alpha) Baseline, 6, and 12 months
Secondary Changes in metabolic function 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. Baseline, 6, and 12 months
Secondary Changes in satiety hormones Markers of satiety that will be measured are: acylated ghrelin, peptide tyrosine tyrosine, GLP-1, leptin, and adiponectin. Baseline, 6, and 12 months
Secondary Changes in quality of life Quality of life will be measured by the a questionnaire Baseline, 6, and 12 months
Secondary Changes in perceived hunger and satiety Perceived hunger and satiety will be assessed by a questionnaire Baseline, 6, and 12 months
Secondary Changes in gut microbiota composition Fecal microbiota composition will be characterized by 16S rRNA gene amplicons sequencing using taxonomic and non-taxonomic based approaches. Baseline, 6, and 12 months
Secondary Changes in gut microbiome functions Fecal microbiome functions will be assessed through whole metagenomic sequencing, stool SCFAs and bile acids, and plasma metabolomics. Baseline, 6, and 12 months
Secondary Changes in intestinal barrier integrity Plasma lipopolysaccharide-binding protein and fecal calprotectin will be determined as measures of gut barrier integrity Baseline, 6, and 12 months
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