The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01119196

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Other: Icodextrin dialysate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: glucose-based dialysate most frequently used Standard of Care (SOC) dialysate
Other: Icodextrin dialysate alternate SOC dialysate	Other: Icodextrin dialysate use of alternate SOC dialysate

Arm

Intervention/Treatment

No Intervention: glucose-based dialysate

most frequently used Standard of Care (SOC) dialysate

Other: Icodextrin dialysate

alternate SOC dialysate

Other: Icodextrin dialysate

use of alternate SOC dialysate

Outcome Measures

Primary Outcome Measures

improvement in glucose disposal rate [12 weeks]

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) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).