The aim of this study was to investigate the effects of enalapril on diabetic neuropathy in patients 30 to 80-year-old with diabetes type 2. The sample size of this study is 124 people including 62 case and 62 control subjects. The main inclusion criteria of the study is having of type 2 diabetes and age between 30 to 80 years.All patients with underlying diseases or under previous treatment with enalapril will be excluded (main exclusion criteria). The duration of this study is 3 months that during this period the case group will treated with enalapril (as the studying intervention) and the control group will receive multivitamin as placebo. Before and after the intervention the EMG-NCV study will be carried out on all patients in order to monitor the consequences of the study (including nerve conduction velocity, nerve conduction amplitude and nerve conduction latency) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061118063N1
Registration date:2014-11-09, 1393/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-09, 1393/08/18
Registrant information
Name
Ali Rajabpour Sanati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1067
Email address
ali.poursanati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Committee of Birjand University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of enalapril on diabetic neuropathy; a double blind clinical trial
Public title
Effect of enalapril on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes type 2 diabetes based on the criteria of american diabetes association (blood sugar after 10 to 12 hours of fasting be more than 126 mg/dl or random BS equal or more than 200 mg/dl) at least for 3 years; Having mild to moderate neuropathy (grade 3 to 5 based on Michigan scoring system); Age between 30 to 80
Exclusion criteria: history of enalapril consumption during a recent year; Consumers of alcohol; Kidney disease patients; Liver disease patients (moderate to severe); The existence of a wound in the foot; amputation of the lower extremities; Developing gestational diabetes in women; history of hereditary neuropathy or background diseases causing neuropathy; Taking TCA antidepressants drugs; A lack of vitamin B12 (not less than 160mg ⁄ dl); A history of renal arteries stenosis; Having one kidney or micro-albuminuria; Sensitivity to ACD inhibitors; Long-term use of non-steroidal inflammatory drugs such as aspirin during the 4 weeks prior to the disease
Case (intervention) group:
after training on drug consumption and emphasis on contact the physician if confronted with drug side effects, they will treated with enalpril (Adibi pharmaceutical company) with 10 mg daily for 3 months. This study will be double-blinded, meaning that both the examiner and the patient will not be informed about the drug type.
Category
Treatment - Drugs
2
Description
Control group:
treated with placebo (multivitamin from ShahrDarou pharmaceutical company), one tablet daily for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Hospital
Full name of responsible person
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research - Birjand University of Medical Sciences
Full name of responsible person
Dr. Zarban
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research - Birjand University of Medical Sciences