Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.

Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.

Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.