All > Type 1 Diabetes > Microbiome

Metformin for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Indiana University School of Medicine, Indianapolis, INType 1 Diabetes+1 MoreMetformin - Drug
Eligibility
11 - 18
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Type 1 Diabetes
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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Diabetes Journey

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 3 years

2 years
Differences in measures Proinsulin as a measure of beta cell health in lean and obese T1D youth
Differences in measures of C-peptide as a measure of beta cell health in lean and obese T1D youth
Differences in measures of insulin sensitivity in lean and obese T1D youth
Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes
Differences in the gut microbiome in lean and obese youth with type 1 diabetes
3 years
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
Changes in measures of proinsulin as a measure of beta cell health in obese T1D youth in response to metformin
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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2
Metformin
2
Stem Cell Educator therapy
1
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Side Effects for

Vildagliptin (LAF237)
13%Nasopharyngitis
10%Hyperhidrosis
9%Hunger
9%Tremor
8%Asthenia
6%Hypoglycaemia
1%Squamous cell carcinoma of the tongue
1%Femoral neck fracture
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02002221) in the Vildagliptin (LAF237) ARM group. Side effects include: Nasopharyngitis with 13%, Hyperhidrosis with 10%, Hunger with 9%, Tremor with 9%, Asthenia with 8%.

Trial Design

2 Treatment Groups

Comparison of microbiome by BMI Category
1 of 2
Metformin
1 of 2

Active Control

Experimental Treatment

114 Total Participants · 2 Treatment Groups

Primary Treatment: Metformin · No Placebo Group · Phase 2

Metformin
Drug
Experimental Group · 1 Intervention: Metformin · Intervention Types: Drug
Comparison of microbiome by BMI CategoryNoIntervention Group · 1 Intervention: Comparison of microbiome by BMI Category · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Heba M. IsmailLead Sponsor

Eligibility Criteria

Age 11 - 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Children and teenagers between 11-18 years old who have type 1 diabetes.
You are between 11-18 years old, have Type 1 Diabetes, and are considered obese.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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