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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
研究概览
简要总结
- 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.
详细描述
- SUMMARY OF THE STUDY
1.1 PROTOCOLE TITLE : A RANDOMIZED, OPEN-LABEL CLINICAL TRIAL TO EVALUATE THE EFFECTS OF ICODEXTRIN Vs 2,5% DIANEAL USED FOR THE LONG-DWELL ON HOMA INDEX IN PREVALENT, NON-DIABETIC, PATIENTS IN AUTOMATED PERITONEAL DIALYSIS (APD)
1.2 MAIN RESEARCHERS: Roberto Pecoits Filho, Thyago P. Moraes
1.3 LOCATION OF STUDY: Multicentric study in Brazil.
1.4 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
时间窗: 3 months
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
次要结局
- Total Ultrafiltration(3 months)
- Oral Fasting Serum Glucose(3 months)
- Glycated Hemoglobin(3 months)
- Serum Insulin(3 months)
研究者
Roberto Pecoits-Filho
MD, PhD, FASN
Pontifícia Universidade Católica do Paraná