Early Phase 1 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial has two separate parts with different eligibility requirements:

Part 1 (Aims 1–3): For people with early-stage type 1 diabetes (Stage 2)

• You are between 12 and 50 years old
• Your body weight falls within a healthy range for your age (BMI 18–31 for adults, or between the 5th and 95th percentile for children/teens)
• You have tested positive for 2 or more diabetes-related antibodies in your blood, AND your blood sugar results fall in a specific "at-risk" range — not yet diabetic, but higher than normal (confirm with trial site for exact test results)

Part 2 (Aim 4): For people recently diagnosed with early-stage type 1 diabetes (Stage 3)

• You are between 12 and 50 years old
• Your body weight falls within a healthy range for your age (BMI 18–31 for adults, or between the 5th and 95th percentile for children/teens)
• Your blood sugar control reading (HbA1c) was between 6.5% and 8.0% at diagnosis, OR between 5.7% and 6.4% with a confirming blood sugar test done within the past 3 months
• Your Stage 3 diabetes diagnosis was made within the last 8 weeks before your first study visit

Who may not be able to join:

For Part 1 (Aims 1–3):

• You have high blood pressure above a certain level (confirm with trial site)
• Your kidneys are not functioning well enough based on a blood test (confirm with trial site)
• Your liver enzyme levels are significantly higher than normal based on blood tests (confirm with trial site)
• Anyone in your family has been diagnosed with a specific type of thyroid cancer called medullary thyroid carcinoma
• You have been diagnosed with pancreas inflammation (pancreatitis) or a stomach-emptying condition (gastroparesis) in the past 3 years
• You are currently taking any diabetes medication, certain blood pressure medications (such as atenolol, metoprolol, or propranolol), antipsychotic medications, steroids, growth hormone, cholesterol-lowering medications, water pills (thiazide diuretics), niacin supplements, certain birth control pills with higher hormone doses, or any medication that suppresses the immune system
• You have taken antioxidant vitamin supplements within 2 weeks before the study
• You are currently pregnant
• You are a woman who is in or past menopause
• You are an active smoker

For Part 2 (Aim 4):

• You have ever been admitted to hospital due to a serious diabetes-related complication called diabetic ketoacidosis (DKA)
• Anyone in your family has been diagnosed with medullary thyroid carcinoma (a specific type of thyroid cancer)
• You have been diagnosed with pancreas inflammation (pancreatitis) or a stomach-emptying condition (gastroparesis) in the past 3 years
• You are currently taking any diabetes medication, certain blood pressure medications (such as atenolol, metoprolol, or propranolol), antipsychotic medications, steroids, growth hormone, cholesterol-lowering medications, water pills (thiazide diuretics), niacin supplements, certain birth control pills with higher hormone doses, or any medication that suppresses the immune system
• You have taken antioxidant vitamin supplements within 2 weeks before the study
• You are currently pregnant
• You are a woman who is in or past menopause
• You are an active smoker

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