Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex
1 other identifier
interventional
124
1 country
1
Brief Summary
This study will define the relationship of cardiac, vascular function and skeletal muscle blood flow (individually and together) to cardiovascular exercise capacity in in men and women with and without type 2 diabetes (T2DM). Identification of differences in the effects of exercise training on the integrated cardiovascular system and metabolism in men and women with and without T2DM will reveal specific adaptive responses to exercise.This study will evaluate \& compare exercise function in a total of 60 subjects from the Denver area (30 people with T2DM and 30 overweight control subjects). Specific Aim 1: To test the hypothesis that the integration of cardiac function, macrovascular function, and microvascular function is impaired in T2D and correlates with cardiovascular exercise capacity (CVEC) impairment. Specific Aim 2: To test the hypothesis that exercise training will elicit adaptive responses in cardiac and vascular function, muscle perfusion and metabolism with differences by T2D status. Differences between the exercise responses in people with T2DM and healthy people will help further identify the disease process of T2DM and direct future research of treatments and interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Feb 2018
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedStudy Start
First participant enrolled
February 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedJuly 12, 2023
July 1, 2023
5.1 years
January 18, 2018
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in peak oxygen consumption (VO2peak)
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months 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
Change in muscular mitochondrial function
The investigators will examine mitochondrial function using magnetic resistance (MR) spectroscopy during single leg calf exercise
Through study completion, approximately 4 months
Study Arms (2)
Type 2 diabetes
EXPERIMENTALMen and women between the ages of 30-55 with well controlled type 2 diabetes (A1C \<9%).
Healthy overweight controls
EXPERIMENTALMen and women between the ages of 30-55 with BMI 25-40 and limited immediate family history of type 2 diabetes.
Interventions
Following the completion of baseline testing, both subject groups will undergo supervised cardiovascular exercise training 3 times per week for 3 months (plus a 3 week ramp-up). Exercise training will take place on a treadmill, stationary bicycle, elliptical, rowing machine, or combination of machines. Each session will last 1 hour, which includes a 5 minute warm-up, 50 minutes of exercise, and a 5 minute cool down.
Eligibility Criteria
You may qualify if:
- Men and women with and without type 2 diabetes
- BMI 25-40
- Sedentary subjects not participating in a regular exercise program (\<one bout of exercise/week)
You may not qualify if:
- 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.
- Peptic ulcer disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Related Publications (2)
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. doi: 10.1186/s12933-025-02999-9. Online ahead of print.
PMID: 41361416DERIVEDAbushamat LA, Enge D, Fujiwara T, Schafer M, Clark EW, Englund EK, Scalzo RL, Johnston A, Rafferty D, Schauer IE, Whipple MO, Hunter K, Huebschmann AG, Nadeau KJ, Jarvis K, Barker AJ, Regensteiner JG, Reusch JEB. Obesity dominates early effects on cardiac structure and arterial stiffness in people with type 2 diabetes. J Hypertens. 2023 Nov 1;41(11):1775-1784. doi: 10.1097/HJH.0000000000003534. Epub 2023 Aug 17.
PMID: 37589719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judy Regensteiner, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
February 1, 2018
Study Start
February 7, 2018
Primary Completion
March 20, 2023
Study Completion
March 20, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share