Clinical trial NCT01219959: Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Official title: Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease (ESRD)
Diabetes
CAPD
Keywords: ESRD
Diabetes
CAPD
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-10-13
Enrollment: 71
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, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) 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 Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD 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.


Eligibility criteria: Inclusion Criteria:

1. Male or Female patients 18 years of age or older
2. Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\]
3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. Diabetes Mellitus (Type 1 and 2)
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
7. Total Kt/V ≥ 1.7

Exclusion Criteria:

1. Blood Urea Nitrogen (BUN) \> 95 mg/dL
2. Exposure to Extraneal within 60 days of Screening
3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77mm Hg) at Screening
4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
5. Cardiovascular event within the last 30 days
6. Ongoing clinically significant congestive heart failure \[New York Heart Association (NYHA) class III or IV\]
7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
8. 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: Armenia
country: Colombia
facility: Nefrosalud Ltda
city: Barranquilla
country: Colombia
facility: RTS Ltda Barranquila
city: Bogota
country: Colombia
facility: RTS Ltda Soledad
city: Bucaramanga
country: Colombia
facility: Rts Ltda Ag H.U.S
city: Cali
country: Colombia
facility: RTS Ltda H.U.V
city: Cali
country: Colombia
facility: RTS Ltda STR del Valle
city: Cali
country: Colombia
facility: RTS Ltda Versalles
city: Cartagena
country: Colombia
facility: Renal Therapy Services (RTS) Ltda Cartagena
city: Cucuta
country: Colombia
facility: RTS Ltda Cucuta
city: Girardot
country: Colombia
facility: RTS Ltda Girardot
city: Ibague
country: Colombia
facility: Unidad Renal de Tolima
city: Medellin
country: Colombia
facility: RTS Ltda Sucursal Medellin
city: Medellin
country: Colombia
facility: RTS Ltda Valle de Aburra
city: Sogamoso
country: Colombia
facility: RTS Ltda Sogamoso
city: Tulua
country: Colombia
facility: RTS Sucrusal Tulua
city: Villavicencio
country: Colombia
facility: RTS Ltda Villavicencio
Study officials:
References: