In this study, the effects of palmitate and chicoric acid on the expression of SIRT1 and IL-6 genes, and the levels of p-AMPK and IL-6 proteins in PBMCs of type 2 diabetic patients and healthy individuals will be investigated. This study is on 40 people (20 people with type 2 diabetes and 20 healthy people). People with type 2 diabetes have fasting blood glucose levels equal to or greater than 126 mg/dL; 2 hours of glucose equal to or greater than 200 mg/dl; HbA1c equal to or greater than 6.5% and are approved by the diagnosis of the endocrinologist. The control group should have a fasting blood sugar lower than 100 mg/dl. Exclude criteria include the use of drugs such as antihypertensive drugs; other acute and chronic inflammatory diseases; pregnancy and.... Blood samples were taken from participants in this study, then the plasma and their PBMC cells are isolated. PBMCs are treated with palmitate and chicoric acid for 24 hours. Then, the effects of palmitate and chicoric acid alone and along with on the expression of SIRT1 and IL-6 genes, and the level of p-AMPK and IL-6 proteins in PBMC cells are investigated. As a result, the effect of chicoric acid on insulin signaling pathway and improvement of status in type 2 diabetics is investigated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071535085N1
Registration date:2017-08-02, 1396/05/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Nasrin Ziamajidi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 672 2548
Email address
n.majidi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects of palmitate and cichoric acid on inflammation pathway in PBMCs of type2 diabetic patient and control group
Public title
The effects of palmitate and chicoric acid on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FBS greater than 126 mg/dL; 2 hours blood glucose greater than 200 mg/dl; HbA1C greater than 6.5%; The control group should have a fasting blood glucose less than 100 mg/dl.
Exclusion criteria:
Use of medications such as antihypertensive drugs (such as beta-blockers), anti-diabetic drugs, estrogen supplements, thyroxine, diuretics and hypolipemic drugs; Other chronic and acute inflammatory diseases such as chronic kidney disease, cardiovascular disease, hypertension and ...; Infectious diseases, cancer, allergies; Other Endocrine Disorders (Except Type 2 Diabetes); Pregnancy; Smoking
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, opposite the People's Park, Hamadan
City
Hamadan
Postal code
6517838678
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.291
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
SIRT1
Timepoint
One day after the intervention, Two day after the intervention
Method of measurement
Gene expression of SIRT1 using Ct of gene
2
Description
IL-6
Timepoint
One day after the intervention, Two day after the intervention
Method of measurement
Gene expression of IL-6 using Ct of gene
3
Description
p-AMPK
Timepoint
One day after the intervention, Two day after the intervention
Method of measurement
concentration of p-AMPK using western blotting
Secondary outcomes
empty
Intervention groups
1
Description
Group (4) treatments with palmitate (500 μM) plus chicoric acid (50 μM), the cells of this group are treated with palmitate at a concentration of 500 μM for 24 hours. Then, they are treated with chicoric acid at a concentration of 50 μM for 24 hours.
Category
Treatment - Drugs
2
Description
Separation of the cells is according to the ficole protocol. In the next step, cell pellets are suspended in the 2 cc culture medium and cell count evaluates using trypan blue. The cells are cultured in the plates in the culture medium. In this environment, a fetal bovine serum 10% and penicillin/streptomycin 1% is added. The cells are kept in a 5% carbon dioxide incubator at 37 °C for 24 hours to keep the cells in stable condition. Then, the cells are divided into four groups:
Group (1) untreated cells
(control group).
The control group contains cells that are treated with a bovine serum albumin 1%
Category
Treatment - Drugs
3
Description
Group (3) treatment with chicoric acid at a concentration of 50 μM. The chicoric acid was dissolved in dimethyl sulfoxide and then reached the desired volume using the culture medium.
The cells of this group were treated with chicoric acid at a concentration of 50 μM for 24 hours.
Category
Treatment - Drugs
4
Description
Group (2) treatment with palmitate with a concentration of 500 μM.
Sodium palmitate was dissolved in 50% ethanol at 55 °C. Then, using a culture medium containing bovine serum albumin 1% reached the desired volume and was sterilized before use.
The cells of this group were treated with palmitate at a concentration of 500 μM for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Ziamajidi
Street address
Department of Clinical Biochemistry, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Department of Clinical Biochemistry, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Ziamajidi
Position
Ph.D
Other areas of specialty/work
Street address
Department of Clinical Biochemistry, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838678
Phone
+98 912 672 2548
Fax
Email
n_ziamajidi@yahoo.com, n.majidi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Ziamajidi
Position
Ph.D
Other areas of specialty/work
Street address
Department of Clinical Biochemistry, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838678
Phone
+98 912 672 2548
Fax
Email
n_ziamajidi@yahoo.com, n.majidi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Ziamajidi
Position
Ph.D
Other areas of specialty/work
Street address
Department of Clinical Biochemistry, Faculty of Medicine, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838678
Phone
+98 912 672 2548
Fax
Email
n_ziamajidi@yahoo.com, n.majidi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)