Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Phase 1

Completed

• Conditions: End-Stage Renal Disease; Dialysis; Hemodialysis
• Interventions: Dietary Supplement: N-acetylcysteine; Dietary Supplement: placebo

• Registration Number: NCT00440869
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.

Detailed Description

Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.

Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules.

Study Timeline

• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Study Start: 2007-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age greater than 18 years
• undergoing hemodialysis for 3 months or more or healthy control without kidney disease

Exclusion Criteria

• inability to give informed consent
• diagnosis of diabetes mellitus
• musculoskeletal contraindication to exercise
• infection requiring intravenous antibiotics within 2 months
• hospitalization within 2 months
• ingestion of antioxidant supplements within one month
• requirement for systemic anticoagulation
• estimated GFR <60 ml/min/1.73 m2 for healthy controls

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N-acetylcysteine	Active
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
change in quadriceps muscle endurance during intermittent submaximal contractions	6 days
change in exercise-induced markers of oxidative stress	8 days

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States