Clinical trial NCT00567398: IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Official title: Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ESRD
Diabetes
Keywords: ESRD
Diabetes
CAPD
APD
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2007-12-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.


Eligibility criteria: Inclusion Criteria:

1. M/F patients 18 years of age or older
2. Diagnosis of ESRD (GFR ≤ 15 mL/min)
3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. DM (Type 1 and 2) on glycemic-control medication, for 90 days
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

1. Cardiovascular event within the last 90 days
2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)
3. Allergy to starch-based polymers
4. Glycogen storage disease
5. Glycogen storage disease
6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77) at Screening.
8. Serum urea \> 30 mmol/L
9. Receiving rosiglitazone maleate

Primary outcomes:
measure: Change From the Baseline Value in HbA1c at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
Secondary outcomes:
measure: Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Number of Severe Hypoglycemic Event Requiring Medical Intervention
timeFrame: Baseline through Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
timeFrame: Baseline and Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
timeFrame: Baseline, Month 3, Month 6 (End of Study)
measure: Change From Baseline of MRI Body Composition at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
measure: Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
timeFrame: Baseline, Month 6 (End of Study)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Southport
country: Australia
facility: Gold Coast Hospital
city: Winnipeg
country: Canada
facility: Saint Boniface General Hospital
state: Manitoba
city: Moncton
country: Canada
facility: Beausejour Hospital Corporation
state: New Brunswick
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Grafton
country: New Zealand
facility: Auckland Hospital
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato DHB
state: Waikato
Study officials:
References:
citation: Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
citation: Delarue J, Maingourd C, Couet C, Vidal S, Bagros P, Lamisse F. Effects of oral glucose on intermediary metabolism in continuous ambulatory peritoneal dialysis patients versus healthy subjects. Perit Dial Int. 1998 Sep-Oct;18(5):505-11.
citation: Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
citation: Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.
citation: Nundy S, Baron JH. The use of neutral red as a peroperative test of vagal innervation. Scand J Gastroenterol. 1975;10(8):847-50.
citation: Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.