Protective effect of a-Lipoic Acid on the Early stage of Diabetic Nephropathy

Completed

Conditions: Early stage of diabetic nephropathy
Urological and Genital Diseases
Glomerular disorders in diabetes mellitus

Registration Number: ISRCTN20939990

Lead Sponsor: Wuxi No. 2 People's Hospital (China)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 62

Inclusion Criteria

1. The diagnosis of diabetic mellitus was based on the guideline of World Health Organization (WHO)
2. Three consecutive 30mg/24h< Urinary Albumin Excretion Rate (UAER)<200mg/24h during the recent 1 month with normal renal function (serum Cr=133µmol/L, BUN=7.1mmol/L)
3. Fasting blood glucose<7.0mmol/L, postprandial blood glucose<10mmol/L, and with stable blood pressure within the range of 140~160mmHg/85~100mmHg.

Exclusion Criteria

1. No obvious symptoms of cardio-cerebrovascular and liver disease, and no recent ketoacidosis, hyperosmotic nonketonic coma , lactic acidosis and no other acute complications.
2. No hyperthyroidism, concurrent infection and other renal disorders
3. No anti-oxidative or nephrotoxic drugs in the recent one month

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting venous blood and total 24-hour urine samples were collected before and after the treatment, subsequently glucose, triglyceride (TG), total cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein (HDL-C) and serum creatine (SCr) were detected by the automatic biochemical analyzer . urinary albumin excretion rates (UAER) was evaluated by radioimmunoassay kit , the content of malondialdehyde (MDA) was assayed by thiobarbituric acid, and the activities of Superoxide Dismutase (SOD) was measured by spectro -photometer assays.<br><br>Laboratory tests including GLU, TG, TC, LDL-C, HDL-C, SCr, were performed at screening, and the second day post the 14-day treatment freshly by the automatic biochemical analyzer. Simultaneously, UAER, MDA and SOD were performed one-time according to the manuals. The samples were collected at the same time points as above and stored in -80?, subsequently thawed and analyzed at the same time.

Secondary Outcome Measures

Name	Time	Method
Endothelium-dependent vasodilator function,referred to brachial arterial flow-mediated dilation (FMD). FMD was measured at screening day and in 48h post the treatment, moreover the time point of test and patient physical position considered.