Trial Outcomes & Findings for Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients (NCT NCT01021878)

NCT ID: NCT01021878

Last Updated: 2014-10-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2014-10-01

Participant Flow

Participant milestones

Measure	Icodextrin glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution N=33	Dextrose Control group, standard treatment Dianeal: glucose based dialysis solution N=27
Overall Study STARTED	33	27
Overall Study Completed Follow-up	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Measure	Icodextrin glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution N=33	Dextrose Control group, standard treatment Dianeal: glucose based dialysis solution N=27
Overall Study Lost to Follow-up	4	3
Overall Study Death	0	1
Overall Study Adverse Event	6	5
Overall Study Transplantation	6	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution	Total n=60 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 15.5 • n=5 Participants	54.1 years STANDARD_DEVIATION 17.4 • n=7 Participants	52.1 years STANDARD_DEVIATION 16.45 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Brazil	33 participants n=5 Participants	27 participants n=7 Participants	60 participants n=5 Participants
HOMA index	2.10 IR score STANDARD_DEVIATION 1.10 • n=5 Participants	1.77 IR score STANDARD_DEVIATION 1.00 • n=7 Participants	1.95 IR score STANDARD_DEVIATION 1.05 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor	1.49 IR score Interval 1.23 to 1.74	1.89 IR score Interval 1.62 to 2.17

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution
Oral Fasting Serum Glucose	92.8 mg/dl 95% Confidence Interval 20.0 • Interval 87.5 to 98.2	94.5 mg/dl 95% Confidence Interval 17.9 • Interval 88.7 to 100.2

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution
Serum Insulin	0.79 log(mmol/L) Interval 0.7 to 0.87	0.90 log(mmol/L) Interval 0.81 to 0.98

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution
Glycated Hemoglobin	4.97 percentage of haemoglobin Interval 4.73 to 5.21	4.86 percentage of haemoglobin Interval 4.62 to 5.1

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Icodextrin n=33 Participants glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	Dextrose n=27 Participants Control group, standard treatment Dianeal: glucose based dialysis solution
Total Ultrafiltration	958 millilitre Interval 818.0 to 1097.0	656 millilitre Interval 517.0 to 795.0

Adverse Events

Icodextrin

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Dextrose

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Icodextrin n=33 participants at risk glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group.	Dextrose n=27 participants at risk Control group, standard treatment Dianeal: glucose based dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group.
Infections and infestations Death	0.00% 0/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	3.7% 1/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.
Infections and infestations Peritonitis	6.1% 2/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	7.4% 2/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.
Skin and subcutaneous tissue disorders Exit-site infection	6.1% 2/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	7.4% 2/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.

Other adverse events

Measure	Icodextrin n=33 participants at risk glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group.	Dextrose n=27 participants at risk Control group, standard treatment Dianeal: glucose based dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group.
General disorders Ultrafiltration Failure	0.00% 0/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	3.7% 1/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.
Musculoskeletal and connective tissue disorders Hernia	3.0% 1/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	0.00% 0/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.
Gastrointestinal disorders gastroesophageal reflux	3.0% 1/33 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.	0.00% 0/27 • 3 months Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.

Additional Information

Dr. Roberto Pecoits-Filho and Dr. Thyago P. Moraes

Pontifícia Universidade Católica do Paraná

Phone: 554132713150

Email: r.pecoits@pucpr.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place