Status:

COMPLETED

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

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

VA Eastern Colorado Health Care System

Conditions:

Type 2 Diabetes Mellitus

Healthy

Eligibility:

All Genders

30-55 years

Phase:

NA

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 withou...

Detailed Description

It is well established that functional exercise capacity and peak oxygen uptake (VO2) are reduced in patients with type 2 diabetes mellitus (T2DM) compared with healthy counterparts. The mechanisms un...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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.

Key Trial Info

Start Date :

February 7 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 20 2023

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT03419195

Start Date

February 7 2018

End Date

March 20 2023

Last Update

July 12 2023

Active Locations (1)

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1

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States, 80045