Type 1 DiabetesZQL010NCT07573228
Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes
A study testing Exercise training in people with Type 1 Diabetes and Overweight, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Overweight
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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)
Who cannot join
- • 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
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- 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%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhenqi Liu, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Zhenqi Liu, MD, 434-924-5247, zl3e@UVAhealth.org
Lee Hartline, MEd, 434-924-5247, lmh9d@virginia.edu
About this study
Official title: Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes (
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Overweight
- Being tested
- Exercise training
- Keywords
- Type 1 diabetes, Exercise training, healthy controls, overweight
- Medical subject headings
- Diabetes Mellitus, Type 1, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
15 weeks of HIIT exercise training
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes - normal weight | Active comparator | Type 1 diabetes normal weight Receives: Other: Exercise training |
| Control - normal weight | Active comparator | healthy control - normal weight Receives: Other: Exercise training |
| Overweight control | Active comparator | Overweight, otherwise healthy Receives: Other: Exercise training |
| Type 1 diabetes - overweight | Active comparator | Type 1 diabetes - overweight Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular blood volume in skeletal and cardiac muscle - changes from baseline
insulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp
Measured: Before and after 15 weeks of exercise training
maximal aerobic exercise capacity
change in VO2max
Measured: before and after 15 weeks of exercise training
Secondary outcomes (2)
insulin-mediated whole body glucose disposal
insulin-mediated whole body glucose disposal during insulin clamp
Measured: before and after 15 weeks of exercise training
Muscle capillary density and satellite cells
Changes in muscle capillary density and satellite cells
Measured: before and after 15 weeks of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start23 Feb 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenqi Liu, University of Virginia
- Investigators
- Zhenqi Liu, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573228
- Sponsor's protocol ID
- 302809
- Other IDs
- R01DK141617
- Acronym
- ZQL010
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes (
- ClinicalTrials.gov ID
- NCT07573228
- Acronym / sponsor ID
- ZQL010 / 302809
- Conditions
- Type 1 Diabetes, Overweight
- Keywords
- Type 1 diabetes, Exercise training, healthy controls, overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes - normal weight | Active comparator | Other: Exercise trainingType 1 diabetes normal weight |
| Control - normal weight | Active comparator | Other: Exercise traininghealthy control - normal weight |
| Overweight control | Active comparator | Other: Exercise trainingOverweight, otherwise healthy |
| Type 1 diabetes - overweight | Active comparator | Other: Exercise trainingType 1 diabetes - overweight |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Male or female ≥21 and ≤50 years old
Key exclusion criteria (14 listed)
- • Acute or chronic disease other than T1D or obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training15 weeks of HIIT exercise training | Other | Control - normal weight, Overweight control, Type 1 diabetes - normal weight, Type 1 diabetes - overweight |
Primary outcome
Microvascular blood volume in skeletal and cardiac muscle - changes from baseline
Time frame: Before and after 15 weeks of exercise training
insulin-mediated changes in skeletal and cardiac muscle as determined by insulin clamp
maximal aerobic exercise capacity
Time frame: before and after 15 weeks of exercise training
change in VO2max
2 secondary outcomes
insulin-mediated whole body glucose disposal
Time frame: before and after 15 weeks of exercise training
Muscle capillary density and satellite cells
Time frame: before and after 15 weeks of exercise training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenqi Liu, MD contact
Zhenqi Liu, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Type 1 Diabetes and Overweight, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Hartline, MEd (434-924-5247, lmh9d@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular blood volume in skeletal and cardiac muscle - changes from baseline (time frame: Before and after 15 weeks of exercise training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.