Back to resultsThe Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Icodextrin dialysate
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Peritoneal Dialysis, Insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Medically stable and receiving stable PD for ≥ 3 months;
- BMI ≤ 45;
- Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
- On Glucose lactate-buffered PD solutions with consistent glucose exposure.
Exclusion Criteria:
- Pregnancy or breast-feeding;
- Intolerance to the study protocols;
- Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone;
- Severe hypokalemia (K+ level < 3.0 mEq/L);
- Hypercalcemia (Ca++ level > 11.0 mg/dL);
- Have a glycogen storage disease;
- Intolerant to maltose or isomaltose;
- Allergic to cornstarch or icodextrin;
- Recent abdominal surgery in the past 30 days;
- Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease;
- Insulin-Dependent Diabetes Mellitus (IDDM).
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
glucose-based dialysate
Icodextrin dialysate
Arm Description
most frequently used Standard of Care (SOC) dialysate
alternate SOC dialysate
Outcomes
Primary Outcome Measures
improvement in glucose disposal rate
Secondary Outcome Measures
the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119196
Brief Title
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Official Title
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Peritoneal Dialysis, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glucose-based dialysate
Arm Type
No Intervention
Arm Description
most frequently used Standard of Care (SOC) dialysate
Arm Title
Icodextrin dialysate
Arm Type
Other
Arm Description
alternate SOC dialysate
Intervention Type
Other
Intervention Name(s)
Icodextrin dialysate
Intervention Description
use of alternate SOC dialysate
Primary Outcome Measure Information:
Title
improvement in glucose disposal rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically stable and receiving stable PD for ≥ 3 months;
BMI ≤ 45;
Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
On Glucose lactate-buffered PD solutions with consistent glucose exposure.
Exclusion Criteria:
Pregnancy or breast-feeding;
Intolerance to the study protocols;
Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone;
Severe hypokalemia (K+ level < 3.0 mEq/L);
Hypercalcemia (Ca++ level > 11.0 mg/dL);
Have a glycogen storage disease;
Intolerant to maltose or isomaltose;
Allergic to cornstarch or icodextrin;
Recent abdominal surgery in the past 30 days;
Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease;
Insulin-Dependent Diabetes Mellitus (IDDM).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
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