Trial Outcomes & Findings for Exercise in Obese Diabetic Patients With Chronic Kidney Disease (NCT NCT01036490)

NCT ID: NCT01036490

Last Updated: 2018-07-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 12 weeks minus baseline
• Results posted on: 2018-07-06

Participant Flow

Subjects were recruited from the outpatient medical clinics of Hines VA Hospital over the three-year period between January 2011 and January 2014

Participant milestones

Measure	Exercise Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control Dietary management alone
Overall Study STARTED	18	18
Overall Study COMPLETED	14	18
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise in Obese Diabetic Patients With Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Exercise n=18 Participants 12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling	Control n=18 Participants Nutritional counseling alone	Total n=36 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 8.7 • n=5 Participants	67 years STANDARD_DEVIATION 7.5 • n=7 Participants	66 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Body mass index	36.2 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants	37.4 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	37 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Proteinuria	-34 mg/g creatinine Interval -236.0 to 247.0	-133 mg/g creatinine Interval -406.0 to -75.0

PRIMARY outcome

Timeframe: 52 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Proteinuria	15 mg/g creatinine Interval -433.0 to 428.0	-66 mg/g creatinine Interval -729.0 to 219.0

SECONDARY outcome

Timeframe: 12 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Albuminuria	-11 mg/g creatinine Interval -148.0 to 203.0	-87 mg/g creatinine Interval -323.0 to 1.0

SECONDARY outcome

Timeframe: 52 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Albuminuria	-13 mg/g creatinine Interval -372.0 to 233.0	-31 mg/g creatinine Interval -598.0 to 238.0

SECONDARY outcome

Timeframe: 12 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Estimated Glomerular Filtration Rate (eGFR)	0.2 mL/min/1.73m^2 Standard Deviation 4.7	-3.4 mL/min/1.73m^2 Standard Deviation 8.9

SECONDARY outcome

Timeframe: 52 weeks minus baseline

Outcome measures

Measure	Exercise n=14 Participants Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.	Control n=18 Participants Dietary management alone
Change in Estimated Glomerular Filtration Rate (eGFR)	-2.0 mL/min/1.73m^2 Standard Deviation 5.8	-3.1 mL/min/1.73m^2 Standard Deviation 6.0

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David J. Leehey, M.D.

Hines VA Hospiral

Phone: (708)2022589

Email: david.leehey@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place