The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119196
• Other study ID #: 100177
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: September 22, 2016
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: September 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Insulin Resistance
• Kidney Failure, Chronic

Intervention

Other:
• Icodextrin dialysate
use of alternate SOC dialysate

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in glucose disposal rate		12 weeks	No
Secondary	the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)		12 weeks	No