Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). The investigators will achieve this goal through a randomized controlled trial of administration of usual protein diet plus KA versus usual protein diet alone in patients on peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study will provide potential avenues for improvement of metabolic profile of patients on PD and possibly improve long-term outcomes such as cardiovascular disease risk and death.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborator: Vanderbilt University
• Treatments: Insulin

Criteria

Inclusion Criteria:

• medically stable and receiving stable PD >= 3 months

• age 18-80 years

• body mass index > 18.5

• Kt/v >= 1.7 or Tccr >= 50l/week/1.73m2

• glucose lactate-buffered PD solutions

Exclusion Criteria:

• pregnancy

• intolerance to the study protocols

• severe, unstable, active, or chronic inflammation disease

• chronic use of anti-inflammatory medication

• severe malnutrition

• a high probability of receiving a kidney transplant or transferring to HD within 6 months

• taking anti-inflammatory medication chronically or taking KA during the past one month