The Measurement of Insulin Resistance in Peritoneal Dialysis Patients

NCT01119196 | Completed DMC

• 1 other identifier: 100177
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Peritoneal Dialysis; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• improvement in glucose disposal rate

  12 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

glucose-based dialysate

NO INTERVENTION

most frequently used Standard of Care (SOC) dialysate

Icodextrin dialysate

OTHER

alternate SOC dialysate

Other: Icodextrin dialysate

Interventions

Icodextrin dialysate OTHER

use of alternate SOC dialysate

Icodextrin dialysate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Insulin Resistance

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

US (1)