Investigating the effect of curcumin-piperine supplementation on oxidative stress index and oxidized LDL in type 2 diabetic patients with high LDL
Design
Placebo-controlled clinical trial
double blind
by accident
Phase 3 on 60 patients
Using Excel software
Settings and conduct
In this study, patients with high LDL referring to Valiasr Hospital, Zanjan if they wish to participate in the study informed consent of them will be taken. After 12 to 14 hours of fasting, 5 cc of blood is taken to measure their blood serum concentrations of lipids, LDL oxidative, stress oxidative parameters and other serum biochemical parameters and kept in the freezer. Participants randomly using the divided randomly classified into two groups: supplement and placebo group.
Participants/Inclusion and exclusion criteria
5 to 10 years have passed since the onset of diabetes, Taking atorvastatin
Glycosylated hemoglobin A1c (HbA1c) between 7 and 9% ,Patients will be included in the study if their LDL blood level is more than 100 mg/dL
Intervention groups
Patients group supplement will be received daily curcumin-piperine for three months and Patients in the control group will be received placebo daily.
Main outcome variables
Low Density Lipoprotein Cholestrol (LDL-C), High Density Lipoprotein Cholestrol (HDL-C), Triglyceride(TG), Total Cholestrol, Fasting Blood Sugar(FBS), HBA1C, LDL oxidative, MDA,SOD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059232N1
Registration date:2023-12-07, 1402/09/16
Registration timing:registered_while_recruiting
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Negin Parsamanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 441 8600
Email address
neginparsa.684@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of curcumin-piperine supplementation on Oxidized LDL and oxidative stress index in patients with type 2 diabetic with high LDL
Public title
Evaluation the effect of curcumin-piperine supplementation on Oxidized LDL and oxidative stress index in patients with type 2 diabetic with high LDL
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
5 to 10 years have passed since the onset of diabetes
Taking atorvastatin
Glycosylated hemoglobin A1c (HbA1c) between 7 and 9%
blood LDL level is more than 200 mg/dL
Exclusion criteria:
Pregnancy or breastfeeding
Participating in concurrent trials
Presence of malignancies
r disease (alanine aminotransferase level three times the upper limit of the normal range)
chronic live, renal failure
chronic inflammatory diseases such as rheumatoid arthritis and acute infections
thyroid disorders (such as hypothyroidism or hyperthyroidism)
obsessive-compulsive disorder
other types of diabetes
receiving hormone or other herbal treatments
hypersensitivity to curcuminoids
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation software was used to randomize the sample into two treatment and placebo groups. Output of mentioned software includes a table that shows the number of each patient is located in each group (intervention or placebo)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study has been designed as double-blind and persons including participants, and investigators, were kept unaware of the treatment administered. Drug and placebo vials have similar packaging and labeling and all recorded data will be encoded in the questionnaires and software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of medical sciences
Street address
Karmandan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
IR.ZUMS.REC.1402.155
Health conditions studied
1
Description of health condition studied
type 2 diabetic patients with high levels of low-density lipoprotein
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
LDL-C
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
2
Description
HDL-C
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
3
Description
TG
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
4
Description
Total Cholestrol
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
5
Description
FBS
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
6
Description
Malondialdehyde
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzyme method using kit
7
Description
Superoxide dismutase
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzyme method using kit
8
Description
Oxidized Ldl
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzyme method using kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500m/gram curcumin per day for 3 months
Category
Treatment - Other
2
Description
Control group: Take placebo (500 mg of lactose) daily for 3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Negin Parsamanesh
Street address
Valiasr square
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Email
neginparsa.684@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Shahin Besharati
Street address
Valiasr square
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 141 0106
Email
shahin.besharati@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shahin Beshrati
Street address
Valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
98
Phone
+98 912 441 8600
Email
neginparsa.684@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Shahin Besharati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Email
shahin.besharati@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
The end of Shahid Fakuri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 122 1496
Email
amir_saheb2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kamyar Mansouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Mahdavi blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Email
kamyarmansori@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the participant’s informations should remain confidental.
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