Clinical trial

Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT07573228

Recruiting nowNot applicableInterventional

What this study is about

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 promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 50 Years
SexAll
Healthy volunteersAccepted
ConditionType 1 Diabetes, Overweight

Full registry criteria

Inclusion 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 access and cardiac imaging. * 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 to limited systemic absorption) Exclusion Criteria: * • 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) * Subjects who are smokers or who have quit smoking \<5 years * Subjects 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 * Subjects 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%

Treatments and study arms

Exercise training

Other

15 weeks of HIIT exercise training

Primary outcomes

Microvascular blood volume in skeletal and cardiac muscle - changes from baselineBefore and after 15 weeks of exercise training

insulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp

maximal aerobic exercise capacitybefore and after 15 weeks of exercise training

change in VO2max

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Virginia🇺🇸 Charlottesville, Virginia, United States
Zhenqi Liu, MDContact
Lee Hartline, MEdContact
Zhenqi Liu, MDPrincipal Investigator