Focus Type 2 Diabetes Related Chronic Kidney Disease
Conditions
Keywords
Exercise, Diabetic kidney disease, vascular function, physical function
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).
Interventions
BEHAVIORALExercise
Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endothelial function measured by brachial artery flow mediated vasodilation | at week 0 and at week 12 | Endothelium-mediated change in in vascular tone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aerobic capacity | at week 0 and at week 12 | Peak oxygen consumption |
| blood pressure | at week 0 and at week 12 | — |
| 24-hour albuminuria | at week 0 and at week 12 | assessed in 30 participants measured in milligram per gram creatinine |
| arterial stiffness measured by pulse wave velocity | at week 0 and at week 12 | — |
| Circulating markers of vascular health | at week 0 and at week 12 | C-reactive protein, isoprostane F2, Asymmetric dimethylarginine |
Countries
United States
Outcome results
None listed