Early Phase 1 Type 1 Diabetes Trial, Recruiting NCT06609356 Sponsor: Vanderbilt University Medical Center Condition: Type 1 Diabetes
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Early Phase 1 Type 1 Diabetes Trial, Recruiting

NCT06609356
Recruiting Early Phase 1

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:

General requirements (all participants):

  • Adults between 18 and 60 years old
  • Body mass index (a measure of weight relative to height) between 18 and 28
  • Weight of at least 50 kg

For people with Type 1 Diabetes (T1DM):

  • Has had Type 1 diabetes for between 1 and 30 years
  • Has an HbA1c (a blood sugar average over roughly 3 months) between 5.7% and 7.5%
  • Is currently using an automated insulin delivery system (such as a closed-loop insulin pump)

For people with GCK-MODY (a specific inherited form of diabetes):

  • Has an HbA1c between 5.7% and 7.5%
  • Has had genetic testing that confirms a GCK gene change linked to this condition

For control participants (people without diabetes):

  • Has an HbA1c below 5.5%

Who may not be able to join:

  • People who have had one or more severe low blood sugar episodes in the past 3 months
  • People who have been admitted to hospital for a serious diabetes-related complication called diabetic ketoacidosis in the past 6 months
  • People with high blood pressure readings above certain levels (confirm with trial site)
  • People whose kidneys are not filtering at a sufficient level, as measured by a blood test (confirm with trial site)
  • People with elevated liver enzyme levels above a certain threshold, as measured by blood tests (confirm with trial site)
  • People with a low red blood cell level (below a certain percentage) as measured by a blood test (confirm with trial site)
  • People who have taken antioxidant vitamin supplements within 2 weeks before the study
  • People currently taking steroid medications (such as cortisone or prednisone) that affect the whole body
  • People currently taking antipsychotic medications
  • People taking certain blood pressure medications, specifically atenolol, metoprolol, or propranolol
  • People taking niacin (a form of vitamin B3 sometimes used for cholesterol)
  • People taking a type of fluid tablet called a thiazide diuretic
  • People taking an oral contraceptive pill containing more than 35 micrograms of ethinyl estradiol
  • People currently taking growth hormone
  • People taking immunosuppressant medications (medicines that reduce the immune system's activity)
  • People taking any blood pressure-lowering medication
  • People taking any cholesterol-lowering medication
  • People who are pregnant
  • People who have not yet reached full physical maturity (confirm with trial site)
  • Women who are peri-menopausal or post-menopausal
  • People who currently smoke

Additional exclusions for Type 1 Diabetes participants only:

  • People taking any diabetes medication other than insulin
  • People whose fasting C-peptide level (a marker of the body's own insulin production) is above 0.7 ng/mL (confirm with trial site)

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Daniel J Moore, MD, PhD, Vanderbilt University Medical Center

Phone: 615-322-7427

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
Early Phase 1
Registry
ClinicalTrials.gov
Start date
3 July 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Aim 1: Tissue glucose disposal (TGD); Aim 2: Nitric Oxide (NO) bioavailability

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