Recruiting

HIIT

Sponsor:

University of Virginia

Code:

NCT07573228

Conditions

Type 1 Diabetes

Overweight

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

Exercise training

Study Details

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.

Conditions

Type 1 Diabetes

Overweight

Study ID

NCT07573228

Start date

Feb 23, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

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%

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Type 1 diabetes - normal weight

Type 1 diabetes normal weight

active comparator: Control - normal weight

healthy control - normal weight

active comparator: Overweight control

Overweight, otherwise healthy

active comparator: Type 1 diabetes - overweight

Type 1 diabetes - overweight

Interventions

Exercise training

15 weeks of HIIT exercise training

Primary outcome measure

  • Microvascular blood volume in skeletal and cardiac muscle - changes from baseline [ Time Frame: Before and after 15 weeks of exercise training ]
  • maximal aerobic exercise capacity [ Time Frame: before and after 15 weeks of exercise training ]

Central Contacts and Locations

Central contacts

Lee Hartline, MEd

434-924-5247lmh9d@virginia.edu

Zhenqi Liu, MD

zl3e@UVAhealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Zhenqi Liu, MD

434-924-5247zl3e@UVAhealth.org

Lee Hartline, MEd

434-924-5247lmh9d@virginia.edu

Principal Investigator:

Zhenqi Liu, MD

More Information

Sponsor

University of Virginia

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Type 1 diabetes
  • Exercise training
  • healthy controls
  • overweight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-05-07.