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

NCT02112071 | Completed DMC

• 3 other identifiers: 0905M66282K23DK082638-0422275
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Diabetic kidney disease; vascular function; physical function

Outcome Measures

Primary Outcomes (1)

• endothelial function measured by brachial artery flow mediated vasodilation

  Endothelium-mediated change in in vascular tone

  at week 0 and at week 12

Secondary Outcomes (5)

• 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

• aerobic capacity

  at week 0 and at week 12

• blood pressure

  at week 0 and at week 12

• 24-hour albuminuria

  at week 0 and at week 12

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

control

NO INTERVENTION

control group asked to continue usual activities

Interventions

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Motor Activity; Diabetic Nephropathies

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ulf G Bronas, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: October 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: October 1, 2013
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

US (1)