Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 30 for:    keto
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT01496092
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : February 21, 2014
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

Tracking Information
First Submitted Date  ICMJE August 19, 2011
First Posted Date  ICMJE December 21, 2011
Last Update Posted Date February 21, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
Insulin resistance [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
Insulin sensitivity will be measured using HOMA-IR.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2011)
Insulin resistance [ Time Frame: 1 year ]
Insulin sensitivity will be measured at basal and stimulated states using HOMA-IR in all subjects and hyperinsulinemic euglycemic clamp in a select group of patients.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • Oxidative stress [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    Oxidative stress will be assessed by Plasma OxLDL.
  • 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).
  • Endothelial dysfunction [ Time Frame: at 0, 12, 24 week after patients start their study prescription ]
    sICAM and sVCAM will be measured.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2011)
  • Oxidative stress [ Time Frame: 1 year ]
    Oxidative stress will be assessed by Plasma F2-isoprostanes which will be measured by GC-MS.
  • Inflammatory state [ Time Frame: 1 year ]
    Inflammatory state will be assessed by C-reactive protein and pro-inflammatory cytokine levels (IL-6, IL-1 and IL-10) using the automated Abbott FLX.
  • Other nutritional markers [ Time Frame: 1 year ]
    Dietary protein intake and dietary energy intake will be estimated by 3-day dietary records. Serum albumin,Serum prealbumin and Lean body mass will be aslo measured for 4 times
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients
Official Title  ICMJE Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance
Intervention  ICMJE Drug: Keto Acid
12 tablets per day
Other Name: Compound α-Ketoacid Tablets
Study Arms  ICMJE
  • Experimental: Keto Acid supplemented with usual protein diet
    Intervention: Drug: Keto Acid
  • No Intervention: usual protein diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2012)
100
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2011)
150
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01496092
Other Study ID Numbers  ICMJE KAPD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong Jie, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Vanderbilt University
Investigators  ICMJE
Principal Investigator: Jie Dong, MD,PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP