Insulin Resistance Clinical Trial
Official title:
Fiber Supplementation and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance: Interactions With the Gut Microbiome.
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. .
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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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