114 Participants Needed

Metformin for Type 1 Diabetes and Obesity

AH
HM
Overseen ByHeba M Ismail
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used metformin before.

Is metformin safe for humans?

Metformin, including its extended-release form, is generally well-tolerated in humans, with studies showing it provides effective blood sugar control without increasing the frequency or severity of side effects at higher doses.12345

How does the drug metformin differ from other treatments for type 1 diabetes and obesity?

Metformin is unique because it helps improve insulin sensitivity and control blood sugar without causing weight gain, and it may even promote some weight loss, which is beneficial for obese patients with type 1 diabetes. Unlike insulin therapy, which often leads to weight gain, metformin offers a weight-neutral or weight-reducing option.26789

What is the purpose of this trial?

Obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with obesity as well as potential mechanisms to modify disease.

Eligibility Criteria

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.

Inclusion Criteria

I am between 11-18 years old, obese, and have Type 1 Diabetes.

Exclusion Criteria

Participation in any research intervention trials within the past 3 months
I have not had an infection or taken antibiotics in the last month.
I have a genetic form of diabetes or Type 2 diabetes confirmed by tests.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin for 6 months to assess changes in gut microbiome and metabolic markers

6 months
Visits at baseline, Month 3, and Month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Metformin
Trial Overview 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.
Participant Groups
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.

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Who Is Running the Clinical Trial?

Heba M. Ismail

Lead Sponsor

Trials
1
Recruited
110+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Long-acting GLP-1 receptor agonists, such as liraglutide and semaglutide, are effective anti-obesity medications that can lead to significant weight loss, with semaglutide showing an average weight loss of 11.6% after one year, compared to 5.5% with liraglutide.
Both medications are generally well tolerated, with similar safety profiles, though they can cause transient gastrointestinal issues; ongoing long-term studies are needed to further evaluate their efficacy and safety.
Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists.Christensen, RM., Juhl, CR., Torekov, SS.[2020]
In a study of 150 patients with type 2 diabetes, extended-release metformin showed comparable efficacy to Glucophage (standard metformin) over 12 weeks, with no significant differences in fasting plasma glucose or HbA1c levels between the two treatments.
Both treatments had mild adverse effects, primarily gastrointestinal, with a slightly higher rate in the extended-release metformin group, but no serious adverse events were reported, indicating that both options are safe for patients.
[Efficacy and safety of extended-release metformin in treatment of type 2 diabetes mellitus].Zhang, JP., Yang, WY., Hong, TP., et al.[2022]
The review highlights that while there are many innovative drugs being developed for type 2 diabetes, several have faced serious safety issues, leading to their withdrawal or halting of development.
It discusses the current state of treatments, including glitazones, incretin mimetics, SGLT-2 inhibitors, and new experimental drugs, emphasizing the need for better methods to predict and differentiate drug-related adverse events from natural disease occurrences.
[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes].Schindler, C., Barthel, A., Fischer, S., et al.[2021]

References

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. [2020]
[Efficacy and safety of extended-release metformin in treatment of type 2 diabetes mellitus]. [2022]
[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. [2021]
Metformin extended release for the treatment of type 2 diabetes mellitus. [2019]
Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes. [2021]
Treatment of obese diabetics. [2016]
[A new era for glucagon-like peptide-1 receptor agonists]. [2023]
Treatment with the long-acting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. [2015]
Pharmacological treatment of the obese diabetic patient. [2018]
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