Overview

Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of essential amino acids in the diet of diabetic nephropathy patients, along with restricted protein diets. This study is designed to explore whether alpha-Keto Acid supplementation with low protein diet will retard progression of type 2 diabetic nephropathy and also to assess effects of such supplemented diets on nutritional and other parameters in this patient group.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fresenius Kabi
Criteria
Inclusion Criteria:

- Age < 75 years, regardless of sex;

- Final diagnosis of type 2 diabetes;

- Plasma glucose is under control (fasting plasma glucose<10mmol/L, glycosylated
hemoglobin<8.0%) with oral glucose-lowering agents (confine to Repaglinide,
α-glycosidase inhibitors, Gliquidone) and /or insulin;

- Even through RAS blocker (ACEI/ARB) is administrated at a fixed dose (the same as the
starting dose, refer to appendix 4) for more than 6 weeks, blood pressure is still ≤
160/90 mmHg;

- Patient is without dialysis and GFR is <60ml/min/1.73m2;

- Overt proteinuria is present two times within 2 weeks (urine albumin > 300mg/d in a
24-h collection)

Exclusion Criteria:

- Diabetic ketoacidosis within the last 6 months;

- Incapable of following study requirements to control diet;

- Glomerular filtration rate < 15 ml/min/1.73m2;

- Hypercalcemia or hyperkalemia (> normal upper limit);

- Other serious disease within the last 3 months;

- With obvious symptoms or signs of liver diseases, ALT or AST > two times normal upper
limit;

- Severe edema or serous cavity effusion;

- Drug abuse

- Final diagnosis of malignant tumor;

- Receiving the long-term systematic steroid hormone treatment;

- Gestation already, prepares to be pregnant in the period of the trial, lactating
women;

- Participate in other product clinical trial within 30 days prior to this trial.