Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes
Objective: The aim of this study is to determine the effects of Morus Alba leaves’ extract supplement on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetes type 2. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with diabetes type 2 with FPG ≥ 126 mg/dl, less than 15 years of their disease and aged 35 to75 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune) and pregnant or lactating women will be included in this study. Population and sample size: 90 patients with diabetes type 2 of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive capsule300 mg Morus Alba leaves’ extract supplement (intervention group), or placebo(control group). Fasting blood samples will be taken at baseline and after12-wk intervention. Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profile, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081312438N21
Registration date:2017-01-12, 1395/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes
Public title
Effect of Morus Alba leaves’s extract supplement on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetes type 2 with FPG ≥ 126 mg/dl; less than 15 years of their disease; aged 35 to 75 years. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with chronic kidney disease; liver; lung; chronic or acute inflammatory diseases; heart valve disease; short bowel syndrome and allergies; patients with low immune system ability (autoimmune); pregnant; lactating.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.KAUMS.REC.1395.57
Health conditions studied
1
Description of health condition studied
Diabets type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
lipid profile
Timepoint
Baseline and End-of-trial
Method of measurement
blood test
5
Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
6
Description
Total glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:300 mg Morus Alba leaves’s extract capsule, 2 times a day for 12 weeks
Category
Treatment - Drugs
2
Description
control group:300 mg placebo capsule, 2 times a day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Science