Clinical trial NCT02112071: Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
Official title: Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus Type 2 Diabetes Related Chronic Kidney Disease
Keywords: Exercise
Diabetic kidney disease
vascular function
physical function
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-04-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
  * 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.

Primary outcomes:
measure: endothelial function measured by brachial artery flow mediated vasodilation
timeFrame: at week 0 and at week 12
Secondary outcomes:
measure: arterial stiffness measured by pulse wave velocity
timeFrame: at week 0 and at week 12
measure: Circulating markers of vascular health
timeFrame: at week 0 and at week 12
measure: aerobic capacity
timeFrame: at week 0 and at week 12
measure: blood pressure
timeFrame: at week 0 and at week 12
measure: 24-hour albuminuria
timeFrame: at week 0 and at week 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ulf G Bronas, PhD
role: PRINCIPAL_INVESTIGATOR
References: