BridgeMD
New treatment option for Obesity, Childhood
Official title Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
ClinicalTrials.gov ID: NCT04578652
What this study is testing
What is Metformin 850 mg oral tablet bid?
Metformin 850 mg oral tablet bid is an investigational medicine, given as an once-daily, being studied as a potential treatment for obesity, childhood.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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).
You likely can't join if
- 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;
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.