Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients (STARCH)

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01021878
First received: November 27, 2009
Last updated: September 30, 2014
Last verified: September 2014
  Purpose
  1. LOCATION OF STUDY: Multicentric study in Brazil.
  2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell.
  3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism.

STAGE OF THE STUDY : Phase IV postmarket study

DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.

SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30 Dianeal® 60 30

Duration: 1 year.


Condition Intervention Phase
Disorders Associated With Peritoneal Dialysis
Other: icodextrin
Other: Dianeal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effects of Icodextrin vs 2.5% Dianeal Used for the Long Dwell in Apd: a Randomized, Open-label Clinical Trial to Analyse the Insulin Resistance Using the Homa Index in Prevalent, Non-diabetic Patients

Resource links provided by NLM:


Further study details as provided by Pontifícia Universidade Católica do Paraná:

Primary Outcome Measures:
  • Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:

    (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405



Secondary Outcome Measures:
  • Oral Fasting Serum Glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Serum glucose measured in oral fasting but not peritoneal fasting.

    For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05.


  • Serum Insulin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.

  • Glycated Hemoglobin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.

    Glycated hemoglobin was measured by high-performance liquid chromatography.


  • Total Ultrafiltration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.


Enrollment: 60
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: icodextrin
glucose sparing alternative dialysis solution
Other: icodextrin
glucose sparing dialysis solution
Other Name: Extraneal
Active Comparator: dextrose
dianeal, Control group, standard treatment
Other: Dianeal
glucose based dialysis solution
Other Name: Dianeal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.10.1 Older than 18 years old.
  • High PET value, average-high or average-low.
  • Cause of renal chronic disease other than diabetes mellitus.
  • Patient in APD
  • Prevalent patient in APD (defined as at least 90 total days of dialysis therapy)

Exclusion Criteria:

  • Not willing to participate.
  • A Charlson comorbidity index >7, or a life expectancy < 12 months as assessed by the treating physician.
  • Positive VIH.
  • Episodes of peritonitis during the month preceding the randomization.
  • Significant cardiovascular, metabolic or infectious complications during the month preceding the randomization.
  • Patients with active cancer.
  • Patients with known allergies to corn starch polymers.
  • Patients who are unable to provide an informed consent because of significant psychiatric disorder or mental illness
  • Patients not meeting adequacy goals several months after the change in the dosage regime.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021878

Locations
Brazil
Hospital São João de Deus
Divinópolis, MG, Brazil
Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, Brazil, 38400 089
Instituto do Rim de Curitiba
Curitiba, Parana, Brazil, 80250-070
Clinica de Doencas Renais
Curitiba, PR, Brazil, 80220901
Nefroclinica de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil, 95010-003
Universidade Estadual Paulista
Botucatu, Sao Paulo, Brazil, 18618970
Clinese
Aracaju, Sergipe, Brazil, 49075210
Universidade Federal de Sao Paulo
Sao Paulo, Brazil, 04023 062
Sponsors and Collaborators
Pontifícia Universidade Católica do Paraná
Baxter Healthcare Corporation
Investigators
Principal Investigator: Roberto Pecoits-Filho, MD, PhD Pontificia Universidade Catolica do Parana
  More Information

No publications provided

Responsible Party: Roberto Pecoits-Filho, MD, PhD, FASN, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01021878     History of Changes
Other Study ID Numbers: PUCPR 01
Study First Received: November 27, 2009
Results First Received: June 24, 2014
Last Updated: September 30, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Pontifícia Universidade Católica do Paraná:
Peritoneal dialysis
Renal replacement therapy
Dialysis solutions
Icodextrin

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Dialysis Solutions
Icodextrin
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014