CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 124 enrolled
Drug / intervention
Cardiovascular exercise trainingother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03419195
NCT03419195N/ACompleted

Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex

University of Colorado, Denver·interventional·Posted Feb 1, 2018·Updated Jul 12, 2023

In Brief

A clinical study evaluating Cardiovascular exercise training for Type 2 Diabetes Mellitus and 3 related conditions. Completed, enrolled 124 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 1, 2018
Enrollment StartFeb 7, 2018
Primary CompletionMar 20, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.4 years ago

Interventions

Cardiovascular exercise trainingother

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.