Determining the effects of atorvastatin consumption on blood levels of sortilin, blood sugar and lipid indices in patients with type 2 diabetes
Design
This research is based on 60 people, and it will be conducted in three groups: These individuals were selected using a simple random method. Patients with type 2 diabetes will receive atorvastatin 40 mg/day for 3 months, and samples will be taken before and after three months of treatment. Healthy people will be sampled in one step, and then the desired variables will be measured.
Settings and conduct
Blood sugar and blood lipid indicators of patients and healthy individuals will be measured in the Shafai Babol laboratory. Serum, sortilin, and insulin levels will be measured using sandwich ELISA in the biochemistry laboratory of the Faculty of Medicine of Kerman University of Medical Sciences. Using serum glucose and insulin concentrations, the HOMA.IR index will be calculated in diabetic patients and healthy individuals.
Participants/Inclusion and exclusion criteria
The statistical population of this research includes patients with type 2 diabetes mellitus who are referred to an endocrinologist (the main collaborator of this project) and healthy (normal) people who are referred to the Shafai Pathology and Medical Diagnosis Laboratory in Babol cityunder the supervision of an endocrinology specialist, Pregnant women and people with a history of cancer or heart attack in the last 6 months were not included in the study.
Intervention groups
Patients with type 2 diabetes before and after treatment with atorvastatin 40 mg/day. Control group are healthy without complications and have no history of special diseases.
Main outcome variables
The effect of atorvastatin on sortilin and blood sugar and lipid indices and the relationship between these factors in patients with type 2 diabetes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231122060137N1
Registration date:2023-12-12, 1402/09/21
Registration timing:registered_while_recruiting
Last update:2023-12-12, 1402/09/21
Update count:0
Registration date
2023-12-12, 1402/09/21
Registrant information
Name
Ali Nosrati andevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4425 3555
Email address
nosrati.ali70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-31, 1402/08/09
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of atorvastatin consumption on blood levels of sortilin, blood sugar and lipid indices in patients with type 2 diabetes
Public title
The effects of atorvastatin consumption in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients have not used statin family drugs before treatment.
Healthy people should visit the laboratory for a routine checkup
Taking atorvastatin 40 mg/day for patients with type 2 diabetes who need treatment with this drug.
Diabetic patients have diabetes for at least 2 years.
Not received insulin in patients with type 2 diabetes and healthy people.
Use of hypoglycemic drugs in patients with type 2 diabetes
Exclusion criteria:
Women who are pregnant or breastfeeding
People who have an active infection or hepatitis B, hepatitis C, HIV, or tuberculosis
History of any cancer
Heart attack in the last 6 months or peripheral coronary artery disease
Smoking and alcohol use
Women who use contraceptives
Indigestion and chronic diarrhea, failure of important organs, such as liver, lung, kidney, and brain, as well as anemia and diabetic nephropathy
Age
From 19 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is a simple random method. In this way, people in the community have an equal chance of being elected. Each element of the desired statistical population has an equal chance of being selected. In this method, the required people are randomly selected from the statistical population list prepared for this purpose. According to the law of probability, the selected people should have the same characteristics as those of the society from which they were selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Mazandaran
Postal code
7616913355
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.KMU.REC.1402.299
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The blood level of sortilin
Timepoint
The mesearment of blood level of sortilin before treatment with atorvastatin and three months after treatment with it
Method of measurement
ELISA method using ELISA reader
2
Description
The levels of blood sugar indices
Timepoint
The mesearment of blood sugar indices before treatment with atorvastatin and three months after treatment with it
Method of measurement
Photometric method using autoanalyzer
3
Description
The levels of blood lipid indices
Timepoint
The mesearment of blood lipid indices before treatment with atorvastatin and three months after treatment with it
Method of measurement
Photometric method using autoanalyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients with type 2 diabetes mellitus before treatment with atorvastatin 40 mg, these diabetic patients have not received atorvastatin so far, samples will be taken from them before treatment with atorvastatin 40 mg per day.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients with type 2 diabetes mellitus after treatment with atorvastatin 40 mg. Patients take this medicine orally for three months
Category
Treatment - Drugs
3
Description
Control group: Healthy people who do not have any diseases and do not take atorvastatin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Neda Meftah
Street address
Kargar Street, University Square, Ganj Afrooz Street, Ayatollah Rouhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 2229 5915
Fax
Email
info@mubabol.ac.ir
Web page address
http://rohani.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Samiya Crossroads (Tahmasababad) at the beginning of Ibn Sina Street, Research and Technology Office
City
Kerman
Province
Kerman
Postal code
0000000000
Phone
+98 34 3226 3719
Email
iranpourabedin89@gmail.com
Web page address
https://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Ali Nosrati Andevari
Position
phd student of clinical biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Kerman University of Medical Sciences Campus, Haft Bagh Alavi highway
City
Kerman
Province
Kerman
Postal code
000000000
Phone
+98 34 3132 5600
Email
nosrati.ali70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Nosrati Andevari
Position
phd student of Clinical Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Kerman University of Medical Sciences Campus, Haft Bagh Alavi highway
City
Kerman
Province
Kerman
Postal code
00000000
Phone
+98 11 3132 5600
Email
nosrati.ali70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Nosrati Andevari
Position
phd student of clinical biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Kerman University of Medical Sciences Campus, Haft Bagh Alavi highway
City
Kerman
Province
Kerman
Postal code
00000000
Phone
+98 11 3132 5600
Email
nosrati.ali70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available