Type 2 DiabetesREACHNCT04791371
Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
A study testing Cardiovascular exercise in people with Type 2 Diabetes and Overweight and Obesity, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight and Obesity
- What is being tested?
- Cardiovascular exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2022to 15 Feb 2027
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary (defined as less than 1 hour per week of physical activity)
- BMI: 25-40
- Men and women with and without type 2 diabetes
Who cannot join
- Documented cardiovascular disease
- Uncontrolled hypertension: disease systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
- Obstructive pulmonary disease or asthma
- Peripheral neuropathy
- Physical impairment that would limit exercise ability
- Subjects taking beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD)
Show all 14Show fewer
- Current or past smoking within the last 1 years
- Current tobacco use
- Anemia
- Control HbA1c > 5.7, T2DM HbA1c > 9
- Pregnant, nursing or hormonal therapy (other than contraceptives)
- Peri or post-menopausal women
- Type 1 diabetes
- Hepatic or renal disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Benjamin Juckett, MS, 303-724-1338, benjamin.juckett@cuanschutz.edu
Ethan Clark, MS, 303-724-1354, ethan.w.clark@cuanschutz.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Lee Hartline, MEd, 434-924-5247, lmh9d@virginia.edu
Linda Jahn, RN, 434-924-1134, las6e@virginia.edu
About this study
The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.
Read the detailed description
It is our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance. Data from our two research teams suggest that the cardiac and skeletal muscle microvascular dysfunction present in people with type 2 diabetes contributes to limitations in cardiac and skeletal muscle function associated with impaired functional exercise capacity (a major predictor of CV and all-cause mortality). Insulin action is a potent predictor of the functional exercise capacity impairment in type 2 diabetes. The exact relationship between insulin action, cardiac and muscle dysfunction, cardiac and skeletal muscle perfusion and decreased functional exercise capacity in type 2 diabetes remains unclear.
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Being tested
- Cardiovascular exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular exerciseBehavioural
15 weeks of cardiovascular exercise 3x/week for 50 minutes/session
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Experimental | Participants aged 30-55 with type 2 diabetes Receives: Behavioral: Cardiovascular exercise |
| Healthy overweight control | Experimental | Participants aged 30-55 with BMI 25-40 without type 2 diabetes Receives: Behavioral: Cardiovascular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen consumption (VO2)
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise
Measured: Through study completion, approximately 4 months
Change in insulin sensitivity
The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp
Measured: Through study completion, approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start17 Jun 2022
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791371
- Sponsor's protocol ID
- 20-2723
- Other IDs
- R01DK124344
- Acronym
- REACH
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park S, Englund EK, Fujiwara T, Enge D, Schafer M, Gerstner Saucedo J, Clark EW, Abushamat LA, Scalzo RL, Fonseca B, Hunter KS, Sammel MD, Regensteiner JG, Reusch JEB, Barker AJ. Comprehensive CMR evaluation including 4D flow-derived E/A vorticity ratio in overweight adults with and without type 2 diabetes mellitus. Cardiovasc Diabetol. 2025 Dec 8;25(1):7. doi: 10.1186/s12933-025-02999-9.
PubMed 41361416
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
- ClinicalTrials.gov ID
- NCT04791371
- Acronym / sponsor ID
- REACH / 20-2723
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Virginia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 10 Mar 2021 (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 goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.
Detailed description
It is our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance. Data from our two research teams suggest that the cardiac and skeletal muscle microvascular dysfunction present in people with type 2 diabetes contributes to limitations in cardiac and skeletal muscle function associated with impaired functional exercise capacity (a major predictor of CV and all-cause mortality). Insulin action is a potent predictor of the functional exercise capacity impairment in type 2 diabetes. The exact relationship between insulin action, cardiac and muscle dysfunction, cardiac and skeletal muscle perfusion and decreased functional exercise capacity in type 2 diabetes remains unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | Experimental | Behavioral: Cardiovascular exerciseParticipants aged 30-55 with type 2 diabetes |
| Healthy overweight control | Experimental | Behavioral: Cardiovascular exerciseParticipants aged 30-55 with BMI 25-40 without type 2 diabetes |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary (defined as less than 1 hour per week of physical activity)
- BMI: 25-40
- Men and women with and without type 2 diabetes
Key exclusion criteria (14 listed)
- Documented cardiovascular disease
- Uncontrolled hypertension: disease systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
- Obstructive pulmonary disease or asthma
- Peripheral neuropathy
- Physical impairment that would limit exercise ability
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 |
|---|---|---|
| Cardiovascular exercise15 weeks of cardiovascular exercise 3x/week for 50 minutes/session | Behavioural | Healthy overweight control, Type 2 Diabetes |
Primary outcome
Change in peak oxygen consumption (VO2)
Time frame: Through study completion, approximately 4 months
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise
Change in insulin sensitivity
Time frame: Through study completion, approximately 4 months
The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp
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 23 Mar 2026.
- Derived from this study: PubMed 41361416Park S, Englund EK, Fujiwara T, Enge D, Schafer M, Gerstner Saucedo J, Clark EW, Abushamat LA, Scalzo RL, Fonseca B, Hunter KS, Sammel MD, Regensteiner JG, Reusch JEB, Barker AJ. Comprehensive CMR evaluation including 4D flow-derived E/A vorticity ratio in overweight adults with and without type 2 diabetes mellitus. Cardiovasc Diabetol. 2025 Dec 8;25(1):7. doi: 10.1186/s12933-025-02999-9.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular exercise in people with Type 2 Diabetes and Overweight and Obesity, run by University of Colorado, Denver at 2 sites 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 3 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Benjamin Juckett, MS (303-724-1338, benjamin.juckett@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen consumption (VO2) (time frame: Through study completion, approximately 4 months). 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?
On the ClinicalTrials.gov record for NCT04791371, which also lists 1 linked publication.
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 23 Mar 2026.