Exercise and Type 2 Diabetes: Gender and Endothelial Function

NCT01993121 | Completed

• 1 other identifier: 02-0514
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

diabetes; exercise; heart; cardiovascular

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in cardiovascular exercise performance

  Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of exercise training.

  baseline and 3 months

• Changes from baseline in cardiovascular exercise performance

  Subjects' oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of exercise training.

  baseline and 3 months

• Changes from baseline in cardiovascular exercise performance

  Subjects' tissue oxygen saturation will be tested during exercise testing before and after 3 months of exercise training.

  baseline and 3 months

Secondary Outcomes (3)

• Changes from baseline in endothelial function will be measured

  baseline and 3 months

• Changes from baseline in endothelial function will be measured

  baseline and 3 months

• Changes from baseline in diastolic function will be measured

  baseline and 3 months

Study Arms (1)

Three-month exercise training program

EXPERIMENTAL

All subjects will perform three months of supervised exercise training.

Other: Supervised Exercise Training

Interventions

Supervised Exercise Training OTHER

All subjects will perform three months of supervised exercise training.

Three-month exercise training program

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 30 and 55 years
• Persons with type 2 diabetes taking only certain oral medications (
• Pre-menopausal women
• Persons with type 2 diabetes who have a total HbA1c level \<9%
• Persons with a BMI between 25-35.

You may not qualify if:

• Current smokers or anyone who has smoked within the last year
• Persons who have clinically evident distal symmetrical neuropathy
• Abnormal lipid levels (total cholesterol \>200, LDL-cholesterol level \>130, or triglyceride level \>250).
• Persons with regional wall motion abnormalities, left ventricular wall thickness \>1.1 cm , or decreased contractility.
• Persons will also be excluded if they have evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (ECG).
• Subjects will be excluded who have peripheral arterial disease.
• Persons with autonomic insufficiency, assessed by measuring variation in RR intervals with cycled breathing and by presence of a \>20 mm fall in upright blood pressure without a change in heart rate, will be excluded.
• Subjects with proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2 mg/dl, suggestive of renal disease will be excluded.
• Controls will not be accepted with an immediate family history of Type 2 Diabetes Mellitis

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Judith G Regensteiner, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2002
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)