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Metformin for Type 1 Diabetes and Obesity

Phase 2
Recruiting
Research Sponsored by Heba M. Ismail
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese youth 11-18 years of age with T1D at time of enrollment.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial looks at the role of the gut microbiome in type 1 diabetes in obese youth, and whether modifying the microbiome can help manage the disease.

Who is the study for?
This trial is for obese and lean youths aged 11-18 with Type 1 Diabetes (T1D). They should not have participated in other research trials within the last 3 months, had infections or antibiotic treatments in the past month, used metformin, or have chronic gastrointestinal diseases including celiac disease. Those with monogenic diabetes forms or immune-compromise conditions are also excluded.Check my eligibility
What is being tested?
The study investigates how obesity affects young people with T1D by looking at their gut bacteria. It's testing whether Metformin, a common Type 2 diabetes medication, can help manage T1D in obese youth by altering their gut microbiome.See study design
What are the potential side effects?
While this summary doesn't specify side effects of Metformin for this trial, generally it may cause digestive issues like stomach pain and diarrhea, taste changes, vitamin B12 deficiency over time, and rarely a serious condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 11-18 years old, obese, and have Type 1 Diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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 the gut microbial metabolites in obese youth with type 1 in response to metformin
Changes in the gut microbiome in obese youth with type 1 diabetes in response to metformin
Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes
+1 more
Secondary outcome measures
Changes in measures of C-peptide as a measure of beta cell health in obese T1D youth in response to metformin
Changes in measures of beta cell function using a timed mixed meal tolerance test
Changes in measures of insulin sensitivity in obese T1D youth in response to metformin
+4 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
This is a group of 30 youth with type 1 diabetes and obesity who will receive metformin for 6 months.
Group II: Comparison of microbiome by BMI CategoryActive Control1 Intervention
The gut microbiome and metabolites of 42 lean and 42 obese youth with type 1 diabetes will be evaluated cross-sectionally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Heba M. IsmailLead Sponsor

Media Library

Metformin Clinical Trial Eligibility Overview. Trial Name: NCT05414409 — Phase 2
Type 1 Diabetes Research Study Groups: Metformin, Comparison of microbiome by BMI Category
Type 1 Diabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05414409 — Phase 2
Metformin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414409 — Phase 2
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05414409 — Phase 2

Frequently Asked Questions

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

Is enrollment for this study currently open?

"Indeed, the most recent update on clinicaltrials.gov states that this research trial is not currently recruiting participants; it was initially posted October 1st 2022 and modified September 16th of the same year. However, there are 2146 other active medical studies actively seeking candidates at present."

Answered by AI

Is this investigation enlisting participants aged 65 or older?

"This clinical trial is open to those between 11 and 18 years old. The number of trials available for minors stands at 410, which significantly outnumbers the 1465 studies targeting seniors."

Answered by AI

What potential risks does Metformin pose to individuals?

"Metformin's safety has been partially verified, so it earned a rating of 2. This is because Phase 2 trials have demonstrated some evidence for its safety but none regarding efficacy."

Answered by AI

What outcomes are researchers aiming to demonstrate with this research endeavor?

"This medical study, which is expected to take around 2 years, will primarily measure the differences in gut microbial metabolites in lean and obese youth with type 1 diabetes. Secondary assessments include changes of insulin sensitivity among overweight T1D patients taking metformin; a comparison between proinsulin levels as an indicator of beta cell health in slim and plump children afflicted with this illness; and contrasting C-peptide measurements for also assessing beta cell health between chubby and slender youngsters suffering from type 1 diabetes."

Answered by AI

What patient criteria must be met to participate in this experiment?

"This clinical trial is calling for 114 obese minors aged 11 to 18 who have type 1 diabetes. To be accepted into the study, applicants must meet two requirements: they must possess T1D when enrolling and either an obesity or lean BMI at the time of enrollment."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Indiana University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've struggled with obesi6 my whole life. I would love to be apart of and help with the research on finding ways to treat obesity.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Heba M. Ismail 2022. "The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05414409.
All > Microbiome
~50 spots leftby Aug 2025
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