Determining the effect of alpha lipoic acid on the symptoms of neuropathy in patients with type 2 diabetes
Design
The study groups are made up of eligible people who visit the diabetes clinic of the hospital. These patients are studied consecutively and under the condition of Ard's consent. Patients are assigned to one of two intervention or control groups using random block design. The sample size is expected to be 80 people. The study phase is 3.
Settings and conduct
After entering to the study and getting consent, and with a clinical history of neuropathy, in addition to their routine medications, patients receive alpha lipoic acid capsules. Patients are entered sequentially and sampling will continue until the research samples are completed. The control group will also receive a similar placebo. The patients of both the intervention and control groups will be referred to the clinic of Ziyaian Hospital of Tehran University of Medical Sciences. The patients and the prescribing doctor will not know which person has been assigned to the intervention group and which one to the control group, because drugs and placebo are designed exactly the same. Blinding is in the sense that the view and understanding of the patient as well as the doctor is not affected by the type of medicine.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 74 years
Having type 2 diabetes
The presence of peripheral neuropathy (pain) in the examination
Exclusion criteria:
Non-entry criteria
Presence of neurological disease such as MS
Severe liver or kidney disease, etc
Intervention groups
The intervention group received 300 mg alpha lipoic acid capsules twice a day
The control group receives a placebo capsule of 300 mg with the same shape and design at the same time
Main outcome variables
Neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230303057599N2
Registration date:2023-07-13, 1402/04/22
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
Mahdi Shafiee Sabet
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7707 8738
Email address
mshafiees@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of alpha lipoic acid on neuropathy in patients with type 2 diabetes.
Public title
The effect of alpha lipoic acid on neuropathy in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 74 years,
Type 2 diabetes,
duration of diabetes more than one year,
presence of peripheral neuropathy (pain) in the examination,
symptoms of neuropathy (pain) for at least one month,
score more than three in the pain diagnostic questionnaire.
Exclusion criteria:
neurological disease such as MS
Severe liver or kidney disease
Antioxidant consumption in the last three months
The presence of cancer and malignancy and chemotherapy
Pregnancy and breastfeeding
Peripheral arterial disease
diabetic foot ulcer
Age
From 18 years old to 74 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks of 4 and 6 will be used for randomization in order to assign patients individually and with equal numbers to intervention and control groups. Random allocation software can also be used.
patient's allocation group after consultation and consent.
Opaque sealed envelopes will be used to conceal allocations.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the research samples are not aware of which drug or placebo they are receiving. Also, the prescribing doctor is not aware of the drug. Only the principal investigator will know whether A or B is drug or placebo. Also, the data analyst will not know which data are for the intervention group and which are for the control group. Medicines are ordered in the form of capsules with the same color, shape and weight for both groups, and it will not be possible for the patient and the prescribing doctor to distinguish them.
Placebo
Used
Assignment
Parallel
Other design features
Patients are consecutively entered into the study and if there are entry criteria and consent to entry, they are allocated to each of the intervention or control groups by random block. The intervention group receives capsules of 300 mg of alpha lipoic acid and the control group receives capsules with the same shape and design, without medicinal substances.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Poorsina
City
Tehran
Province
Tehran
Postal code
88953003
Approval date
2021-08-14, 1400/05/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.538
Health conditions studied
1
Description of health condition studied
Diabetes - type 2
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Neuropathy
Timepoint
At the beginning of the study and then once a month until the completion of the probationary period
Method of measurement
Physical examination
2
Description
pain
Timepoint
At the beginning of the study and then once a month until the completion of the probationary period
Method of measurement
visual analog scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive 300 mg capsules of alphalipoic acid (Raha Pharmaceutical Company) twice a day. In order to receive the capsule, the necessary educational explanations are given by the doctor to both the intervention and control groups. Also, all the drugs used by the patients in both groups will be recorded. In addition, these patients have routine tests of CBC, blood sugar, etc. The patients will be given medicine for one month and at the end of the first, second and third month they will be examined. Also, information is obtained from the patients' compliance with alphalipoic acid medication. Patients only know that they are under research and have consented to enter the study, but they are not aware of receiving drugs or placebo.
Category
Treatment - Drugs
2
Description
Control group: After obtaining consent following the review of entry criteria, the patients assigned to the control group will receive a placebo(Raha Pharmaceutical Company) instead of alphalipoic acid capsules, which the patients and the prescribing doctor do not know whether it is a drug or a placebo. The patients will receive the medicine for one month and will return every month, and the intervention group will receive all the training and examinations from the prescribing doctor. Also, the patient will be asked about the consumption of capsules. Medications taken by the patient are also checked and recorded during the course
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Mahdi Shafiee Sabet
Street address
Qala Morghi St. - Abu Dhar St., District 17 Municipality
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
mshafiees@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Shafiee Sabet
Street address
poursina
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5517 6813
Email
mshafiees@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Shafiee Sabet
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Qala Morghi St. - Abu Dhar St., District 17 Municipality
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5575 1333
Email
mshafiees@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Shafiee Sabet
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Qala Morghi St. - Abu Dhar St., District 17 Municipality
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5575 1333
Email
mshafiees@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Shafiee Sabet
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Qala Morghi St. - Abu Dhar St., District 17 Municipality
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5575 1333
Email
mshafiees@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
To share the data, all the data after deidentification in the form of excel or spss files regarding all the desired consequences can be provided to the officials of the ministry to help in developing the protocol. Also, researchers can get the file after the request from the link that will be designed.
When the data will become available and for how long
Access starts three months after the publication of the article
To whom data/document is available
Hospital managers and doctors with permission from the principal investigator
Under which criteria data/document could be used
For the purpose of secondary analysis on the data by presenting the approved design code
From where data/document is obtainable
Dr. Mahdi Shafiee Sabet
mshafiees@sina.tums.ac.ir
What processes are involved for a request to access data/document
The request can be made in writing and officially by the registration in the automation system, etc. to the main researcher