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

Launched by UNIVERSITY OF ALBERTA · Oct 1, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how well a combination of dietary fiber and a medication called metformin works for teenagers aged 12 to 18 who are struggling with severe obesity and insulin resistance. Insulin resistance means the body doesn't use insulin effectively, which can lead to higher blood sugar levels. The researchers want to see if taking fiber and metformin together can improve weight, insulin sensitivity, and inflammation more than either treatment alone. Over the course of 12 months, participants will be monitored for changes in their weight, insulin levels, and gut health.

To be eligible for this study, participants need to be between 12 and 18 years old and have a body mass index (BMI) above the 95th percentile for their age and sex, along with other health indicators. However, those currently using insulin, diagnosed with type 2 diabetes, or with certain health conditions will not be able to participate. If chosen for the trial, participants can expect to take the treatments and attend regular check-ups to track their progress. This study is important because it could help find better ways to manage obesity and related health issues in adolescents.

Gender

ALL

Eligibility criteria

• 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.