Obesity's effect on muscle insulin action and cardiorespiratory fitness in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare adults with type 1 diabetes (with and without obesity) to matched healthy controls, measuring muscle microvascular insulin responsiveness and cardiorespiratory fitness before and after a supervised high-intensity interval training (HIIT) program. The protocol includes baseline and post-training physiological testing, measures of muscle oxidative stress, mitochondrial function, capillary density, and satellite cell counts to explore mechanisms. Participants are adults aged 21–50 with defined BMI ranges and stable diabetes management, and the intervention is structured exercise training with pre/post tissue and vascular assessments. The design tests whether obesity worsens microvascular insulin resistance and whether that predicts declines in fitness that can be modified by HIIT.

Why it matters

Who can join: the full rules

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%

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Zhenqi Liu, MD — University of Virginia
• Study coordinator: Lee Hartline, MEd
• Email: lmh9d@virginia.edu
• Phone: 434-924-5247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.