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

Protective effect of a-Lipoic Acid on the Early stage of Diabetic Nephropathy via reducing oxidative stress and improving vascular endothelium function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20939990

Enrollment

Registered

2013-09-04

Start date

2011-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The study subjects were divided into two groups randomly, control group and therapy group. Both control and therapeutic group subjects received regular hypoglycemic therapy and strict diabetes diet,

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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

Measure	Time frame
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.	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026