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.