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New treatment option for Type 1 Diabetes
Official title Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes
ClinicalTrials.gov ID: NCT07573228
What this study is testing
- What it's testing
- The purpose of this study is: To see if insulin resistance (how sensitive your muscle tissue is to insulin) is associated with lower cardio fitness in people with Type 1 diabetes compared to healthy controls, before and after a High Intensity Interval Training (HIIT) exercise program. To see if being overweight and having Type 1 diabetes is associated with lower cardio fitness compared to overweight healthy controls, before and after a HIIT exercise program.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Male or female ≥21 and ≤50 years old
- For persons with T1D: Disease duration ≥ 5 years and HbA1c ≤ 8.5% on multiple daily insulin injection or insulin pump
- Body mass index: ≥19 and ≤27 kg/m2 for control and T1D, ≥30 and ≤40 kg/m2 (27.5 to 37.5 for Asian Americans) for obesity and T1D + obesity. BMI is...
- Stable use of non-insulin medications for over 6 months other than estrogen/progesterone containing medications which must be discontinued at least 3...
You likely can't join if
- Acute or chronic disease other than T1D or obesity
- History of microvascular or macrovascular diabetes complications
- History of diabetic ketoacidosis in the past 24 months
- History of hypoglycemia unawareness
- Recently active (\>20 min of moderate/high intensity exercise, 2 times/week)
- people who are smokers or who have quit smoking \<5 years
See the full eligibility criteria
- Male or female ≥21 and ≤50 years old
- For persons with T1D: Disease duration ≥ 5 years and HbA1c ≤ 8.5% on multiple daily insulin injection or insulin pump
- Body mass index: ≥19 and ≤27 kg/m2 for control and T1D, ≥30 and ≤40 kg/m2 (27.5 to 37.5 for Asian Americans) for obesity and T1D + obesity. BMI is limited to ≤40 kg/m2 (37.5 for Asian Americans) for easier vascular...
- Stable use of non-insulin medications for over 6 months other than estrogen/progesterone containing medications which must be discontinued at least 3 months prior to the study (intrauterine devices may be continued due...
- Acute or chronic disease other than T1D or obesity
- History of microvascular or macrovascular diabetes complications
- History of diabetic ketoacidosis in the past 24 months
- History of hypoglycemia unawareness
- Recently active (\>20 min of moderate/high intensity exercise, 2 times/week)
- people who are smokers or who have quit smoking \<5 years
- people with hypertriglyceridemia (\>400 mg/dl)
- Current use of vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha- or beta-blockers, or diuretics).
- Females taking oral contraceptives in the past 3 months
- people with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Musculoskeletal condition preventing participation in exercise testing or exercise training
- History of gastroparesis
- Pulse oximetry \<90%
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.