Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.

NCT ID: NCT02112071

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-10-31

Brief Summary

The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).

Conditions

Focus Type 2 Diabetes Related Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

blended supervised-hombased exercise training 3-4 times/week for 12 weeks

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.

control

control group asked to continue usual activities

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• • An individual must be >18 years of age

Have diagnosed type 2 diabetic mellitus by one of the following criteria:

o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).

If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.

Diagnosed kidney attributed to diabetes by one of the following criteria:3

• Macroalbuminuria (ACR >300mg/g, or)
• Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).
• An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.
• At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.

• An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
• Individuals must be able to provide informed consent
• Perform walking exercise testing on a treadmill
• Be able to participate in a 12-week supervised exercise program.

Exclusion Criteria

• • Patients are currently exercising

• Requiring dialysis
• Have an Hematocrit <30%
• Uncontrolled hypertension (>200/100mmHg)
• Peripheral vascular disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulf G Bronas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

K23DK082638-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22275

Identifier Type: OTHER

Identifier Source: secondary_id

0905M66282

Identifier Type: -

Identifier Source: org_study_id