Focus Type 2 Diabetes Related Chronic Kidney Disease Clinical Trial
— DKD-EXTOfficial title:
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
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).
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | October 2013 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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. - An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Minnesota | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | endothelial function measured by brachial artery flow mediated vasodilation | Endothelium-mediated change in in vascular tone | at week 0 and at week 12 | No |
| Secondary | arterial stiffness measured by pulse wave velocity | at week 0 and at week 12 | No | |
| Secondary | Circulating markers of vascular health | C-reactive protein, isoprostane F2, Asymmetric dimethylarginine | at week 0 and at week 12 | No |
| Secondary | aerobic capacity | Peak oxygen consumption | at week 0 and at week 12 | No |
| Secondary | blood pressure | at week 0 and at week 12 | No | |
| Secondary | 24-hour albuminuria | assessed in 30 participants measured in milligram per gram creatinine | at week 0 and at week 12 | No |