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Biguanide

Fiber + Metformin for Severe Childhood Obesity and Insulin Resistance

Phase 3

Recruiting

Led By Andrea M Haqq, MD, MHS

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-18 years

BMI percentile > 95% for age/sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, and 12 months

Awards & highlights

Study Summary

This trial will compare the effects of two different treatments (MET and fiber) on weight, insulin sensitivity, and inflammation in adolescents with obesity, IR, and a family history of T2DM. The hypothesis is that the combination of the two treatments will be more effective than either one alone.

Who is the study for?

Adolescents aged 12-18 with severe obesity and insulin resistance can join this trial. They must have a family history of type 2 diabetes, be significantly overweight for their age/sex, and not have had major weight changes or taken certain medications recently.Check my eligibility

What is being tested?

The study is testing if a high-fiber supplement mix works better alone or combined with Metformin to improve blood sugar control, reduce body mass index (BMI), and lower inflammation in obese teens over one year.See study design

What are the potential side effects?

Possible side effects include digestive discomfort from the fiber such as gas or bloating. Metformin may cause stomach upset, diarrhea, nausea/vomiting, and there's a rare risk of vitamin B12 deficiency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

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My BMI is in the top 5% for my age and sex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in HOMA-IR

Secondary outcome measures

Changes in body composition

Changes in body mass index (BMI)

Changes in body weight

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: FIBER + METExperimental Treatment2 Interventions

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

Group II: FIBERActive Control1 Intervention

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

Group III: METActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,868 Total Patients Enrolled

Andrea M Haqq, MD, MHSPrincipal InvestigatorUniversity of Alberta

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT04578652 — Phase 3

Insulin Resistance Research Study Groups: FIBER + MET, FIBER, MET

Insulin Resistance Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04578652 — Phase 3

Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04578652 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors welcome to participate in this research study?

"People aged 12 to 18 are eligible for this trial, as indicated by the inclusion criteria. In total, there are 883 clinical trials available for people over 65 and 294 for those younger than 18 years old."

Answered by AI

What other scientific observations have been made about this combination of dietary fiber?

"Currently, there are a total of 180 ongoing clinical trials for Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX. Out of these, 45 are in Phase 3. Most of the trials for this medication are being conducted in Rockville, Maryland; however, there are 1952 locations across the country where clinical trials for this drug are taking place."

Answered by AI

Are we still accepting patients for this research program?

"Yes, this trial is still open and currently recruiting patients. According to the information available on clinicaltrials.gov, which was last updated on April 1st, 2022, they are looking for 90 participants at 1 location."

Answered by AI

What condition is Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX. used to commonly treat?

"The supplement mixture, which contains a total of 35 grams of fiber, is made up of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g. It is most often used to treat exercise-related conditions but has also been shown to be effective in the treatment type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

How many people are consenting to participate in this experiment?

"Yes, according to the most recent update on clinicaltrials.gov, this trial is currently looking for 90 patients from a single site. The study was originally posted on October 22nd, 2021."

Answered by AI