Diabetes and peritoneal dialysis Nutritional, Metabolic, Endocrine
Conditions
Interventions
We will prospectively and consecutively enroll the diabetic peritoneal dialysis patients (n=60) to participate this clinical trial. Study subjects will be randomly allocated by sealed envelope into th
n=30) and the control group (standardized pharmacotherapy, including antihyperglycemic medicines
n=30).
The dulaglutide therapy will be maintained for one year, and the patients will be followed up for one year to answer the primary and secondary endpoints.
Sponsors
Chang Gung Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CKD with a clinical cause of diabetes mellitus 2. Age is = 20 and= 75 years 3. The subject had been receiving peritoneal dialysis for more than 3 months. 4. The subject treat with or without OHAs or insulin treatment 5. The subject doesn’t treated with GLP-1 analogue 6. The subject is able and willing to return for required follow-up visits and examinations.
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant or breastfeeding 2. Participants who have any of the following medical conditions: 2.1. Chronic inflammatory or autoimmune diseases 2.2. Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver disease 2.3. CKD from causes other than diabetes 2.4. Cancer (malignancy) 2.5. Febrile illnesses 2.6. Age is 75 years 2.7. The subject has a life expectancy of less than one years. 2.8. The subject has allergic reaction to any GLP-1 analogues. 2.9. HIV infection- the virus that causes AIDS 2.10. The subject is deemed by study physicians to be unsuitable for enrollment. 2.11. The subject is currently enrolled in another investigational study or registry that would directly/indirectly interfere with the current study. 2.12. The subject is unable or unwilling to return for required follow-up and examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from Baseline in the Mean Peritoneal Fluid Glucose ratio (D4/D0) after 12 Months of Treatment with Dulaglutide. [Time Frame: baseline, 6 months and 12 months] The mean glucose concentrations will be evaluated by the Peritoneal Equilibrium Test from Baseline and after 6 and 12 months with Dulaglutide treatment. The peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid. The concentration of glucose in the dialysis fluid (D4) at 4 hours is divided by the glucose in the dialysis fluid at the beginning (D0), generating the D4/D0. 2. Change from Baseline in the Mean Ultrafiltration Volume after 12 Months of Treatment with Dulaglutide. [Time Frame: baseline, 6 months and 12 months] Ultrafiltration volume from Baseline and after 6 and 12 months with Dulaglutide treatment assessment by the Peritoneal Equilibrium Test. The modified peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid. 3. Change from Baseline in the Mean 4 Hour Peritoneal Fluid to Plasma Creatinine (D/P) after 12 Months of Treatment with Dulaglutide. [Time Frame: baseline, 6 months and 12 months] The peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine and urea using a 4.5% dextrose peritoneal fluid. The concentration of creatinine in the dialysis fluid (D) at 4 hours is divided by the plasma creatinine (P), generating the D/P creatinine. 4. Change from Baseline in the Mean 4 Hour Peritoneal Fluid to Plasma BUN (D/P) after 12 Months of Treatment with Dulaglutide. [Time Frame: baseline, 6 months and 12 months] The peritoneal equilibration test (PET) characterizes the peritoneal transport of fluid, creatinine | — |
Secondary
| Measure | Time frame |
|---|---|
| [Time frame: baseline (pre-treatment), and 12 months (post-treatment)]. 1. Incidence rate of ultrafiltration failure measured using patient records 2. Incidence rate of peritoneal dialysis failure (i.e., peritoneal dialysis transfer to hemodialysis) 3. Incidence rate of peritonitis measured using patient records 4. Preservation of residual renal function in dialysis patients (i.e., 24-hour urinary urea and creatinine clearance and urine total protein to creatinine ratio) | — |
Countries
Taiwan
Contacts
Public ContactHon-Kan Yip
Outcome results
None listed