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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573228
Acronym
ZQL010
Enrollment
60
Registered
2026-05-07
Start date
2026-02-23
Completion date
2030-06-30
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Type 1 Diabetes

Keywords

Type 1 diabetes, Exercise training, healthy controls, overweight

Brief summary

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.

Detailed description

This study will test the hypothesis that in humans with T1D skeletal muscle microvascular insulin resistance predicts a reduction in Cardiorespiratory Fitness (CRF) and obesity exacerbates microvascular insulin resistance, leading to further CRF decline, which is mechanistically linked to increased muscle microvascular endothelial oxidative stress, impaired muscle mitochondrial function, reduced muscle capillary density and decreased satellite cells.

Interventions

OTHERExercise training

15 weeks of HIIT exercise training

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes

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%

Design outcomes

Primary

MeasureTime frameDescription
Microvascular blood volume in skeletal and cardiac muscle - changes from baselineBefore and after 15 weeks of exercise traininginsulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp
maximal aerobic exercise capacitybefore and after 15 weeks of exercise trainingchange in VO2max

Secondary

MeasureTime frameDescription
insulin-mediated whole body glucose disposalbefore and after 15 weeks of exercise traininginsulin-mediated whole body glucose disposal during insulin clamp
Muscle capillary density and satellite cellsbefore and after 15 weeks of exercise trainingChanges in muscle capillary density and satellite cells

Countries

United States

Contacts

CONTACTLee Hartline, MEd
lmh9d@virginia.edu434-924-5247
CONTACTZhenqi Liu, MD
zl3e@UVAhealth.org
PRINCIPAL_INVESTIGATORZhenqi Liu, MD

University of Virginia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026