Type 1 DiabetesPhase 2NCT05414409
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
A Phase 2 study testing Metformin in people with Type 1 Diabetes and Obesity, run by Heba M. Ismail at 1 site in United States.
Trial summary
Ovwerweight and 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 overweight and obesity as… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Obesity
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
- Lean youth 11-18 years of age with T1D at time of enrollment.
Who cannot join
- Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
- History of ongoing infection or antibiotic treatment within the past month;
- History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
- History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
- Participation in any research intervention trials within the past 3 months.
- History of treatment or use of metformin, a type 2 diabetes medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Heba Ismail, 317-278-7856, heismail@iu.edu
HI Team, 317-278-7042, hiteam@iu.edu
About this study
Official title: The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
Ovwerweight and 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 overweight and obesity as well as potential mechanisms to modify disease.
- Conditions
- Type 1 Diabetes, Obesity
- Being tested
- Metformin
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin is an oral medication that improves insulin sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of microbiome by BMI Category | No intervention | The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally. |
| Metformin | Experimental | This is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes
cross sectional comparison of stool microbiome using metagenomic sequencing data
Measured: Baseline
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry
Measured: Baseline
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry
Measured: Baseline
Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin
longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing
Measured: Baseline, Month 3, and Month 6
Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin
The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry
Measured: Baseline, Month 3, and Month 6
Secondary outcomes (7)
Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth
The investigators will measure serum C-peptide to calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.
Measured: Baseline
Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth
The investigators will measure serum proinsulin and calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.
Measured: Baseline
Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth
Insulin sensitivity will be assessed in individuals using the estimated insulin sensitivity score (eIS), which is based on waist circumference (cm), HbA1c (%) and triglycerides (mg/dl)
Measured: Baseline
Changes in measures of C-peptide as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Serum C-peptide will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy
Measured: Baseline, Month 3, and Month 6
Changes in measures of proinsulin as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Serum proinsulin will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy
Measured: Baseline, Month 3, and Month 6
Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin
Estimated insulin sensitivity score will be used to assess response metformin therapy
Measured: Baseline, Month 3, and Month 6
Changes in measures of beta cell function using a timed mixed meal tolerance test
Participants in the metformin trial will undergo a standard 2-hour mixed meal tolerance test at baseline and after 6 months of oral metformin therapy
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start30 Sep 2022
- Primary completion2 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The investigators will examine the differences in the gut microbiome between lean and overweight/obese youth with type 1 diabetes and then enroll the overweight/obese youth with type 1 diabetes into the clinical trial to receive metformin as an intervention.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heba M. Ismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heba M. Ismail, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414409
- Sponsor's protocol ID
- 15498
- Other IDs
- 1K23DK129799
- Status last verified
- Jul 2026
- First submitted
- 31 May 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin
- ClinicalTrials.gov ID
- NCT05414409
- Acronym / sponsor ID
- 15498
- Conditions
- Type 1 Diabetes, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Heba M. IsmailUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovwerweight and 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 overweight and obesity as well as potential mechanisms to modify disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will examine the differences in the gut microbiome between lean and overweight/obese youth with type 1 diabetes and then enroll the overweight/obese youth with type 1 diabetes into the clinical trial to receive metformin as an intervention.
| Arm | Type | Receives |
|---|---|---|
| Comparison of microbiome by BMI Category | No intervention | –The gut microbiome and metabolites of 42 lean and 42 overweight/obese youth with type 1 diabetes will be evaluated cross-sectionally. |
| Metformin | Experimental | Drug: MetforminThis is a group of 30 youth with type 1 diabetes and overweight/obesity who will receive metformin for 6 months. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
- Lean youth 11-18 years of age with T1D at time of enrollment.
Key exclusion criteria (6 listed)
- Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
- History of ongoing infection or antibiotic treatment within the past month;
- History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
- History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
- Participation in any research intervention trials within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin is an oral medication that improves insulin sensitivity. | Drug | Metformin |
Primary outcome
Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
cross sectional comparison of stool microbiome using metagenomic sequencing data
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry
Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin
Time frame: Baseline, Month 3, and Month 6
longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing
Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin
Time frame: Baseline, Month 3, and Month 6
The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry
7 secondary outcomes
Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth
Time frame: Baseline
Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth
Time frame: Baseline
Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth
Time frame: Baseline
Changes in measures of C-peptide as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Time frame: Baseline, Month 3, and Month 6
Changes in measures of proinsulin as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Time frame: Baseline, Month 3, and Month 6
Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin
Time frame: Baseline, Month 3, and Month 6
Changes in measures of beta cell function using a timed mixed meal tolerance test
Time frame: Baseline and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Type 1 Diabetes and Obesity, run by Heba M. Ismail at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba M Ismail (317-274-2114, heismail@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.