The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01119196

Enrollment

Registered

2010-05-07

Start date

2010-09-30

Completion date

2015-01-31

Last updated

2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Peritoneal Dialysis, Insulin resistance

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.

Interventions

OTHERIcodextrin dialysate

use of alternate SOC dialysate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame
improvement in glucose disposal rate	12 weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026