Determining the effects of Ellagic acid on inflammation and insulin resistance in patients with Type 2 diabetes mellitus and acute coronary syndrome
Design
A randomized, three-blind, placebo-controlled phase 3 clinical trial with parallel groups on 80 patients. Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward and clinic of Imam Reza Hospital in Mashhad. Patients are randomly assigned to Ellagic acid and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Type 2 diabetes mellitus; Patients with a history of myocardial infarction based on the American Heart Association criteria; At least 6 months have passed since the diagnosis of diabetes; Age over 18 years; Consent to admission to the study; Fasting serum glucose levels greater than or equal to 125 mg/dl; Glycosylated hemoglobin blood levels greater than or equal to 6.5%.
Not-Inclusion criteria: Type 1 diabetes; Kidney failure and GFR<30; Severe liver failure with liver enzymes more than 3 times normal; Chronic inflammatory disease such as lupus; Pregnancy; Breastfeeding.
Exclusion criteria: Lack of consent to continue the study
Intervention groups
Intervention Group: Patients with Type 2 diabetes mellitus and acute coronary syndrome receiving ٍEllagic acid 200 mg once daily for two months along with common treatments.
Placebo Group: Patients with Type 2 diabetes mellitus and acute coronary syndrome receiving ٍplacebo capsules once daily for two months along with common treatments.
Main outcome variables
Primary outcome: Changes in the HOMA-IR at the beginning and after 8 weeks.
Secondary outcome: Changes in the level of CBC diff., Total Cholesterol, HDL, LDL, Insulin, HbA1c, FBS, hs-CRP, Urea, and creatinine at the beginning and after 8 weeks.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N14
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Ellagic acid on inflammation and insulin resistance in patients with Type 2 diabetes mellitus and acute coronary syndrome
Public title
Evaluation of the effects of Ellagic acid on inflammation and insulin resistance in patients with Type 2 diabetes mellitus and acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus
Patients with a history of myocardial infarction according to the American College of Heart criteria
At least 6 months have passed since the diagnosis of diabetes
Age more than 18 years old
Consent to admission to the study
Patients with fasting serum glucose levels greater than or equal to 125 mg/dl
Patients with glycosylated hemoglobin blood levels greater than or equal to 6.5%
Exclusion criteria:
Type 1 diabetes
Kidney failure and GFR<30
Severe liver failure with liver enzymes three times more than normal
Chronic inflammatory disease such as lupus
Pregnancy
Breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 20 blocks according to the sample size of 80. Then, random numbers between 1 and 20 are selected according to the randomization site Randomaization.com, and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Changes in hs-CRP serum level
Timepoint
At the beginning of the study and after 4 weeks of treatment
Method of measurement
Laboratory kit
2
Description
Changes in CBC diff
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
3
Description
Changes in lipid profile
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
4
Description
Changes in Insulin levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
5
Description
Changes in fasting blood sugar levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
6
Description
Changes in Hemoglobin A1c levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
7
Description
Changes in Urea levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
8
Description
Changes in Creatinine levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
9
Description
Changes in ALT levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
10
Description
Changes in AST levels
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
11
Description
Changes in Interleukin-6 level
Timepoint
At the beginning of the study and after 8 weeks of treatment
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: Patients with Type 2 diabetes mellitus and acute coronary syndrome receiving Ellagic acid 200 mg once daily for two months along with standard treatment.
Category
Treatment - Drugs
2
Description
Control group: Patients with Type 2 diabetes mellitus and acute coronary syndrome receiving placebo capsule with the same shape and size once daily for two months along with standard treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Cardiology, Imam Reza Hospital
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Street address
Imam Reza hospital, Ebnsina Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
baradaranrv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available