Phase 2 Type 1 Diabetes Trial, Recruiting NCT05414409 Sponsor: Heba M. Ismail Condition: Type 1 Diabetes
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Phase 2 Type 1 Diabetes Trial, Recruiting

NCT05414409
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Young people aged 11 to 18 who have Type 1 diabetes and are overweight or obese
  • Young people aged 11 to 18 who have Type 1 diabetes and have a lean body type

Who may not be able to join:

  • People who have a rare inherited form of diabetes (monogenic diabetes) or Type 2 diabetes, as confirmed by clinical and lab testing
  • People who have had an active infection or taken antibiotics in the past month
  • People who have a weakened immune system, get infections often, or have used steroids (inhaled or oral) or other immune-suppressing medications in the past 6 months
  • People who have a long-term digestive or gut condition that has been active in the past 6 months, or who have possible or confirmed celiac disease
  • People who have taken part in another research intervention trial in the past 3 months
  • People who have ever been treated with metformin, a medication used for Type 2 diabetes

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 317-274-2114

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Heba M. Ismail
Registry
ClinicalTrials.gov
Start date
30 September 2022
Est. completion
2 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes; Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes; Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes; Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin; Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov