Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients (STARCH)
- LOCATION OF STUDY: Multicentric study in Brazil.
- 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.
- 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.
Disorders Associated With Peritoneal Dialysis
|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|
- 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
- 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.
|Study Start Date:||October 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
glucose sparing alternative dialysis solution
glucose sparing dialysis solution
Other Name: Extraneal
Active Comparator: dextrose
dianeal, Control group, standard treatment
glucose based dialysis solution
Other Name: Dianeal
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021878
|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|
|Aracaju, Sergipe, Brazil, 49075210|
|Universidade Federal de Sao Paulo|
|Sao Paulo, Brazil, 04023 062|
|Principal Investigator:||Roberto Pecoits-Filho, MD, PhD||Pontificia Universidade Catolica do Parana|