Exercise and Type 2 Diabetes: Gender and Endothelial Function

Type 2 Diabetes Clinical Trial

Official title: Exercise and Type 2 Diabetes: Gender and Endothelial Function

Status Completed

Clinical Trial Summary

The objective of the current proposal is to evaluate the importance of blood vessel dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and their contribution to the gender differences observed in exercise capacity. Importantly, treatments that improve blood vessel function in persons with type 2 diabetes can be used to directly assess whether impairment in blood vessel function and ultimately exercise performance, can be improved and whether the degree of improvement differs between the sexes.

Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women than men.

Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in women with type 2 diabetes than men and contribute to the gender differences in exercise capacity.

Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in women than men with type 2 diabetes.

Clinical Trial Description

Subjects will come in for a total of seven research visits. Four initial study visits before exercise training for three months and then subjects will repeat the testing.

1. Initial exam. A history and physical exam will be performed. Blood will be drawn for measurements of overall health. Resting electrocardiogram will be obtained. The Low Level Physical Activity Recall (LOPAR) questionnaire will be administered.

2. Dual Energy X-ray Absorptiometry (DEXA) will be carried out during visit two. A familiarization bicycle ergometer test will also be performed on this day.

3. During visit three, a euglycemic clamp will be performed.

4. During visit four, echocardiographic measurements will be made and a diet interview will be performed.

5. On visit five, measures of blood vessel-dependent vasodilation will be performed. Repeated brachial artery diameter and forearm blood flow responses to cuff occlusion will be measured separately on this occasion.

6. On visit six, arterial stiffness will be measured. Subjects will also perform a graded bicycle exercise test.

7. On visit seven, subjects will perform constant level bicycle tests. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT01993121
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Completed
• Phase: N/A
• Start date: September 2002
• Completion date: September 2008