Condition category
Urological and Genital Diseases
Date applied
16/08/2013
Date assigned
04/09/2013
Last edited
09/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study to investigate the effects of α-lipoic acid (α-LA) in early diabetic nephropathy (kidney disease in diabetic patients). Our goal is to evaluate the protective effects of α-LA on the vascular endothelium function (blood circulation) through improving the oxidative stress in early diabetic nephropathy patients. We want to compare a series of clinical biochemical markers, particularly flow-mediated dilation (FMD), within the two different groups. The study's findings should boost the administration of α-LA in the treatment for early diabetic nephropathy.

Who can participate?
The study aims to recruit about 62 early diabetic nephropathy patients with type 2 diabetes.

What does the study involve?
Over a period of two weeks participants will be randomly allocated to receive either a regular therapy strategy or α-LA plus regular therapy. At the screening, we will collect blood samples or measure the basal flow-mediated dilation (FMD) value, and after the 14-day treatment interval corresponding samples and measurements will be collected and tested.

What are the possible benefits and risks of participating?
The results of the study are likely to confirm α-LA as a potent anti-oxidative agent that could protect susceptible kidney cells from oxidative damage.
There will be no immediate direct risk of administration of α-LA in the treatment of early diabetic nephropathy.

Where is the study run from?
The study has been set up by the Wuxi No.2 People’s Hospital, China.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in January 2011. Participants will be enrolled on the study for a period of about two weeks; however, the study will extend beyond this as we intend to look at participants’ health over several months to assist future studies about α-LA administration in early diabetic nephropathy.

Who is funding the study?
Funding has been provided by Wuxi No.2 People’s Hospital, China.

Who is the main contact?
Ph.D. Huiming Sheng, Immune1004@gmail.com
Professor. Weifeng Yao, yaowf68@sohu.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Huiming Sheng

ORCID ID

Contact details

68 Zhongshan road
wuxi
214002
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

LAEDN

Study hypothesis

Protective effect of α-Lipoic Acid on the early stage of diabetic nephropathy via reducing oxidative stress and improving vascular endothelium function.

Ethics approval

Ethical Committee of the Wuxi No.2 Hospital, 18 Dec 2011

Study design

Two groups randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early stage of diabetic nephropathy

Intervention

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, moreover, during the treatment, no antiplatelet, anticoagulants, vascular dilation, lipid-lowering and Angiotensin-Converting Enzyme Inhibitors(ACEI) drugs were administered. In addition, α-lipoic acid (Alpha-Lipon®, Eisai China Inc.) was given intravenously with 600 mg/day, for 2 weeks for therapeutic group only.

Intervention type

Drug

Phase

Not Applicable

Drug names

α-Lipoic Acid

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/01/2011

Overall trial end date

30/12/2013

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62

Participant 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

Recruitment start date

01/01/2011

Recruitment end date

30/12/2013

Locations

Countries of recruitment

China

Trial participating centre

68 Zhongshan road
wuxi
214002
China

Sponsor information

Organisation

Wuxi No. 2 People's Hospital (China)

Sponsor details

68 Zhongshan road
wuxi
214002
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wuxi No. 2 People's Hospital (China) - pilot funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes