Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients
Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 21, 2014
February 1, 2014
1.7 years
August 19, 2011
February 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin resistance
Insulin sensitivity will be measured using HOMA-IR.
at 0, 12, 24 week after patients start their study prescription
Secondary Outcomes (3)
Oxidative stress
at 0, 12, 24 week after patients start their study prescription
Inflammatory state
at 0, 12, 24 week after patients start their study prescription
Endothelial dysfunction
at 0, 12, 24 week after patients start their study prescription
Study Arms (2)
Keto Acid supplemented with usual protein diet
EXPERIMENTALusual protein diet
NO INTERVENTIONInterventions
12 tablets per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University First Hospitallead
- Vanderbilt Universitycollaborator
Study Sites (1)
Jie Dong
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Dong, MD,PhD
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of Nephrology, Division of Renal
Study Record Dates
First Submitted
August 19, 2011
First Posted
December 21, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 21, 2014
Record last verified: 2014-02