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Clinical Trial NCT04791371 (REACH) for Type 2 Diabetes, Overweight and Obesity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes (REACH)
Clinical Trial NCT04791371 (REACH) is an interventional study for Type 2 Diabetes, Overweight and Obesity that is recruiting. It started on June 17, 2022 with plans to enroll 150 participants. Led by University of Colorado, Denver, it is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 12, 2025.
Brief 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. 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.
Official Title
Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
Conditions
TYPE 2 DiabetesOverweight and ObesityOther Study IDs
- REACH
- 20-2723
- R01DK124344 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2022-06-17
Last Update Posted
2025-03-12
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalType 2 Diabetes Participants aged 30-55 with type 2 diabetes | Cardiovascular Exercise 15 weeks of cardiovascular exercise 3x/week for 50 minutes/session |
ExperimentalHealthy overweight control Participants aged 30-55 with BMI 25-40 without type 2 diabetes | Cardiovascular Exercise 15 weeks of cardiovascular exercise 3x/week for 50 minutes/session |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in peak oxygen consumption (VO2) | Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise | Through study completion, approximately 4 months |
Change in insulin sensitivity | The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp | Through study completion, approximately 4 months |
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
30 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Sedentary (defined as less than 1 hour per week of physical activity)
- BMI: 25-40
- Men and women with and without type 2 diabetes
- 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)
- 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.
University of Virginia296 active trials to explore
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Central Contact
Contact: Benjamin Juckett, MS, 303-724-1338, [email protected]
2 Study Locations in 1 Countries
Colorado
University of Colorado, Aurora, Colorado, 80045, United States
Benjamin Juckett, MS, Contact, 303-724-1338, [email protected]
Ethan Clark, MS, Contact, 303-724-1354, [email protected]
Judy Regensteiner, PhD, Principal Investigator
Jane Reusch, MD, Principal Investigator
Recruiting
Virginia
University of Virginia, Charlottesville, Virginia, 22908, United States
Lee Hartline, MEd, Contact, 434-924-5247, [email protected]
Linda Jahn, RN, Contact, 434-924-1134, [email protected]
Zhenqi Liu, MD, Principal Investigator
Recruiting