Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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)
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise training
Other intervention15 weeks of HIIT exercise training
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Type 1 diabetes - normal weightActive comparator 1 intervention
Group B: Control - normal weightActive comparator 1 intervention
Group C: Overweight controlActive comparator 1 intervention
Group D: Type 1 diabetes - overweightActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Microvascular blood volume in skeletal and cardiac muscle - changes from baseline
insulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp
Time frame
Before and after 15 weeks of exercise training2
maximal aerobic exercise capacity
change in VO2max
Time frame
before and after 15 weeks of exercise trainingSecondary outcomes
1
insulin-mediated whole body glucose disposal
insulin-mediated whole body glucose disposal during insulin clamp
Time frame
before and after 15 weeks of exercise training2
Muscle capillary density and satellite cells
Changes in muscle capillary density and satellite cells
Time frame
before and after 15 weeks of exercise trainingSponsors and contacts
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Source ClinicalTrials.gov