Protocol summary
-
Study aim
-
Improving glycemic status, insulin resistance, antioxidant status and inflammatory factors in patients with type 2 diabetes
-
Design
-
In this study, 44 patients with type 2 diabetes who are eligible for inclusion in the study and referred to the Department of Endocrinology and Metabolism of Velayat Hospital of Qazvin University of Medical Sciences are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.
-
Settings and conduct
-
This study will be done by referring to the Specialty Hospital of Qazvin University of Medical Sciences. The intervention and control group will receive 200 mg of ellagic acid or placebo daily for 2 months, respectively. Each person will complete questionnaires of consent, individual, physical activity, and 24-hour recall. Fasting blood samples were also collected at the beginning and end of the study in 10 ml from participants. In this study, participants will be randomly divided into two groups (22 persons) through the table of random numbers.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: willingness to work, type 2 diabetes, age 25- 55, non-modification of treatment and medications for at least the past 2 months, moderate physical activity
Exclusion criteria: Use of insulin, diabetes for more than 10 years, pregnancy and lactation, patients with severe renal and hepatic dysfunction, alcohol consumption
-
Intervention groups
-
Intervention group: the group receiving ellagic acid (200mg daily) Control group: placebo group
-
Main outcome variables
-
Fasting blood sugar, 2 hours sugar, Glycosylated hemoglobin, insulin resistance, lipid profile, oxidative stress indices, inflammatory factors, expression of miR146-a, SIRT1, and Fetuin A
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20141025019669N13
Registration date:
2019-09-24, 1398/07/02
Registration timing:
registered_while_recruiting
Last update:
2019-10-11, 1398/07/19
Update count:
1
-
Registration date
-
2019-09-24, 1398/07/02
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-08-31, 1398/06/09
-
Expected recruitment end date
-
2019-11-30, 1398/09/09
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Assessment the ellagic acid supplementation effect on glycemic status, insulin resistance, inflammatory factors, antioxidant status and expression of miR146-a in patients with type 2 diabetes: double blind randomized clinical trial
-
Public title
-
Ellagic acid supplementation effect in patients with type 2 diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Men and women with with type 2 diabetes
Willingness to work
Age 25- 55
Non-modification of treatment and medications for at least the past 2 months
Moderate physical activity
Exclusion criteria:
Insulin using
Having diabetes for more than ten years
Pregnancy and breastfeeding
Patients with severe renal and hepatic dysfunction,
Alcohol consumption
-
Age
-
From 24 years old to 55 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
44
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
It will be done randomly using lottery method. Each patient will receive a number or code, and then we will write the numbers on pieces of paper. We will then place the pieces of paper in a container and select the samples according to the sample size.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Supplements and placebo will be placed in similar containers and encode by someone except investigator, so patients and the investigator will be blinded to medicine and placebo groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-07-19, 1398/04/28
-
Ethics committee reference number
-
IR.QUMS.REC.1398.079
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
-
Fasting blood sugar
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
2
-
Description
-
2 hours sugar
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
3
-
Description
-
Insulin resistance
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Using the formula
4
-
Description
-
Glycosylated hemoglobin
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
5
-
Description
-
Lipid profile
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
6
-
Description
-
Total antioxidant capacity
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
7
-
Description
-
Glutathione peroxidase enzyme
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
8
-
Description
-
Superoxide dismutase enzyme
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
9
-
Description
-
Malondialdehyde
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
10
-
Description
-
Inflammatory factors
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
11
-
Description
-
Expression of miR146-a
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Real-Time PCR
12
-
Description
-
SIRT1
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
13
-
Description
-
Fetuin A
-
Timepoint
-
Before the intervention and after the intervention
-
Method of measurement
-
Eliza
14
-
Description
-
Sleep quality
-
Timepoint
-
Before intervention and after intervention
-
Method of measurement
-
Petersburg’s sleep quality questionnaire
Intervention groups
1
-
Description
-
Intervention group: Ellagic acid, a capsule 200 mg per daily for two months, Manufacturer: Supplement Spot
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: A daily placebo capsule containing wheat flour for two months
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Vice-Chancellor for Research of Qazvin 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
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
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
All data after people are unrecognizable
-
When the data will become available and for how long
-
After completing the study and analyzing the data
-
To whom data/document is available
-
All researchers
-
Under which criteria data/document could be used
-
There is no objection to the use of data provided the source of the resource.
-
From where data/document is obtainable
-
By contacting the email address of a person responsible for general inquiries
khademnut@yahoo.com
-
What processes are involved for a request to access data/document
-
Six months after the study
-
Comments
-