Effects of supplementation with curcumin on serum lipid level in patients with type 2 diabetes mellitus and co-existence dislipidemia: A randomized placebo-controlled trial
Determining the effects of supplementation with curcumin on serum lipid level in patients with type 2 diabetes mellitus and co-existent dislipidemia
Design
A concealed, randomized, triple blind, placebo-controlled clinical trial with a parallel group design of 80 patients. Website "www.randomizer.org" will be used for generating randomization list.
Settings and conduct
Patients with type 2 diabetes mellitus and co-existent dislipidemia admitted to endocrinology clinic in Imam Reza Hospital in Mashhad are study population. Patinets will be allocated to two study groups as intervention and palcebo. Patients, researcher and assessors will be kept blind in this study. Lipid and glocuos profile (FBS,HbA1C,2hpp, LDL,HDL,TG, Cholesterol) will be assessed before and after intervention (12 weeks later) in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetic melitusis; co-existance of dyslipidemia; Patient consent to participate in the study.
Non inclusion criteria: Pregnancy and breast feeding; malignancy; chronic liver disease; renal failure; chronic inflammatory disease; acute infection; other endocrine diseases; liver and bladder obstructive diseases
Intervention groups
Intervention group: curcumin (500mg) and piperin (5mg) with standard treatment for 12 weeks.
Placebo group : placebo with standard treatment for 12 weeks.
Effects of supplementation with curcumin on serum lipid level in patients with type 2 diabetes mellitus and co-existence dislipidemia: A randomized placebo-controlled trial
Public title
Curcumin effect in patients with type 2 diabetes mellitus and co-existent dislipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with with type 2 diabetes mellitus based on FPG≥ 126 mg/dL, glycated hemoglobin (HbA1C) ≥ 6.5% OR treatment with antidiabetic drugs.
Co-existence of dislipidemia
Patient consent to participate in the study
Exclusion criteria:
Pregnancy and breast feeding
Malignancy
Chronic liver dysfunction (alt,ast >3 fold more than normal)
Kidny dysfunction (cr>2)
Chronic inflammatory diseases
Acute infection diseases
Endocrine diseases
Psychology diseases
Secondary causes of hypoglycemia
Drug use
Change the antidiabetic drugs
Obstructive billiary and liver diseases
History of gallbladder stones
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method, the random number sequences will be generated through https://www.Randomization.com. The random number sequences are determined for the required sample size (n=40 in each group). Following, after patients enter the study based on the inclusion criteria, according to the list of the random number sequences generated, individuals are allocated to one of the intervention and placebo groups, and this continues until the number of patients in each group is completed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Using drugs with similar shape, smelling and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committees of Mashhad University of Medical Sciences
Street address
Clinical Reasearch Unit, Imam Reza Hospital, Ebne Sina street.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.596
Health conditions studied
1
Description of health condition studied
patients with type 2 diabetes mellitus and co-existence dislipidemia
ICD-10 code
E11.69
ICD-10 code description
Type 2 diabetes mellitus with other specified complication
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
before intervention and 12 weeks after intervention
Method of measurement
Lab test on blood sample
2
Description
LDL (low-density lipoprotein)
Timepoint
before intervention and 12 weeks after
Method of measurement
Lab test on blood sample
3
Description
Hemoglobin A1C
Timepoint
before intervention and 12 weeks after
Method of measurement
Lab test on blood sample
4
Description
HDL (High-density lipoprotein)
Timepoint
before intervention and 12 weeks after
Method of measurement
Lab test on blood sample
5
Description
TG (Triglyceride)
Timepoint
before intervention and 12 weeks after
Method of measurement
Lab test on blood sample
6
Description
Total Cholesterol
Timepoint
before intervention and 12 weeks after
Method of measurement
Lab test on blood sample
Secondary outcomes
1
Description
Body mass index
Timepoint
before intervention and 12 weeks after
Method of measurement
weight and hight mesurment
Intervention groups
1
Description
Intervention group: Patients with type 2 diabetes mellitus and co-existence dislipidemia will recieve curcumin 500 mg and piperidin 5mg with standard care for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients with type 2 diabetes mellitus and co-existence dislipidemia will recieve placebo with standard care for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Solmaz Hasani
Street address
Imam Reza Hospital, Ebne Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2089
Email
Morovatdarn@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour Mobarhan
Street address
Clinical Rsearch Unit, Imam Reza Hospital, Ebne Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2089
Email
morovatdarn@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
Solmaz Hasani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospita; Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
0098513
Email
HasaniS@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negar Morovatdar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Imam Reza Hospita; Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2089
Email
morovatdarn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negar Morovatdar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Imam Reza Hospita; Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3802 2089
Email
morovatdarn@mums.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
Principal investigators are committed to presenting all the achivements of the project based on the Mashhad University of Medical Sciences protocol.