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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496092
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : February 21, 2014
Vanderbilt University
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: Keto Acid Phase 3

Detailed Description:

Specific Aims and Significance:

To evaluate the effects of KA plus usual protein diet on basal and stimulated insulin sensitivity in PD patients.

Hypothesis: Administration of KA plus usual protein diet will improve insulin resistance in peritoneal dialysis patients.

To evaluate the influence of KA plus usual protein diet on non-traditional cardiovascular disease (CVD) markers (markers of inflammation and oxidative stress) in PD patients.

Hypothesis: Administration of KA plus usual protein diet will improve markers of inflammation and oxidative stress in PD patients.

Background and Rationale:

Insulin Resistance in Peritoneal Dialysis Patients. Insulin resistance (IR), the reciprocal of insulin sensitivity, describes a state of reduced biological effect for any given concentration of insulin in the plasma. Insulin resistance plays a major pathophysiological role in glucose intolerance and Type 2 diabetes mellitus (T2DM) and is tightly associated with major public health problems including obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Insulin resistance, measured by homeostatic model assessment (HOMA-IR), is reported to be common in chronic kidney disease (CKD) patients, including ones on PD and hemodialysis (HD). HOMA-IR is also shown to be an independent predictor of cardiovascular mortality in non-diabetic maintenance HD patients although the pathophysiological link has not been clearly delineated.

A unique aspect of PD that predisposes patients to IR is the inevitable glucose load from the dialysate required for ultrafiltration. Consequently, the prevalence of metabolic syndrome such as hyperglycemia, dyslipidemia and weight gain is increased in PD patients. As an individual component of metabolic syndrome, IR is significantly higher in PD patients than in HD or pre-dialysis patients (47% vs 21% or 26%). Accordingly, improvement of IR could be a potential intervention to decrease the CVD risk and mortality in PD patients. However, only a few investigations have centered on interventions to ameliorate IR in these patients.

Low Protein Diet Supplemented with Keto Acid as a Potential Strategy to Ameliorate Insulin Resistance in PD Patients. Several small scale studies exploring the effects of low protein diet (LPD) plus KA on glucose metabolism indicated that LPD-KA could improve liver and peripheral tissue insulin sensitivity in CKD patients not yet on maintenance dialysis. There are no studies exploring such effects in maintenance dialysis patients, especially in PD patients. One potential mechanism for the improvement in insulin resistance by KA is the reduction of circulating uremic toxins, although the specific elements are not well delineated. In addition, the supplementation of KA might be helpful since plasma total branched-chain amino acid concentrations correlate with glucose tolerance index in dialysis patients. Since the safety of LPD has not been entirely shown in previous studies for PD patients, and our data indicated that DPI < 0.74g/kg/d was harmful in the long-term PD, the investigators will not provide the LPD for improving the IR. However, the exploration of possible benefits of KA plus usual protein intake in PD patients on insulin sensitivity is intriguing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Keto Acid supplemented with usual protein diet Drug: Keto Acid
12 tablets per day
Other Name: Compound α-Ketoacid Tablets

No Intervention: usual protein diet

Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    Insulin sensitivity will be measured using HOMA-IR.

Secondary Outcome Measures :
  1. Oxidative stress [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    Oxidative stress will be assessed by Plasma OxLDL.

  2. Inflammatory state [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    Inflammatory state will be assessed by C-reactive protein, pro-inflammatory cytokine levels (IL-6) and adipokines (leptin and adiponectin).

  3. Endothelial dysfunction [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    sICAM and sVCAM will be measured.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496092

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China, Beijing
Jie Dong
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Vanderbilt University
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Principal Investigator: Jie Dong, MD,PhD Peking University First Hospital
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Responsible Party: Dong Jie, Institute of Nephrology, Division of Renal, Peking University First Hospital Identifier: NCT01496092    
Other Study ID Numbers: KAPD
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014
Keywords provided by Dong Jie, Peking University First Hospital:
Keto Acid
Peritoneal dialysis
Insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases