Evaluation of the effect of L-carnitine supplementation on homocysteine, total antioxidant capacity, fasting blood glucose and lipid profile in patients with type 2 diabetes
The aim of this study is evaluating the effect of L-carnitine supplementation on homocysteine, total antioxidant capacity, fasting blood glucose and lipid profile in patients with type 2 diabetes. 66 diabetic patients will be randomly and double blinded divide into two intervention and control groups. The intervention consisted of 2 groups: 1. Two 500 mg/day L-carnitine tablet and 2.Two 500 mg/day Placebo. Anthropometric indices, biochemical, general and medical information and food records for each person will be collected at the baseline and at the end of the study. Duration of intervention will be 3 months.Individuals with following conditions will be excluded: Patients with Kidney disease; Hypothyroid patients that they were not treated; People with blood pressure upper than 150/90 mm; Use of L-carnitine and B group vitamins during the last 3 months; Antioxidant supplementation use (vitamins A, A, D and E) within 1 month Past; Smoking and hookah; Liver and gastrointestinal diseases; Having a systematic infection or surgery history 3 or 6 months ago; History of heart attacks; Unstable angina or congestion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100936681N1
Registration date:2017-10-28, 1396/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Nasir Talenezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
n.talenezhad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of L-carnitine supplementation on homocysteine, total antioxidant capacity, fasting blood glucose and lipid profile in patients with type 2 diabetes
Public title
The Effect of L-Carnitine Supplementation on Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Body mass index between 25 and 35; People aged 30 to 60 years old; Diabetes mellitus patients and HbA1c hemoglobin less than 9 percent and Exclusion criteria: Kidney disease; Hypothyroid patients who were not treated; People with blood pressure upper than 150/90 mm; Use of L-carnitine and B group vitamins during last 3 months; Antioxidant supplementation use (vitamins A, A, D and E) within 1 month Past; smoking ; liver and gastrointestinal diseases; having a systematic infection or surgery history 3 or 6 months ago; history of heart attacks, unstable angina or congestion.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8915173160
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SSU.SPH.REC.1396.90
Health conditions studied
1
Description of health condition studied
type 2 diabetes mellitus
ICD-10 code
E-11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
serum homocysteine
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
ELISA
2
Description
Total antioxidant capacity(TAC)
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
ELISA
3
Description
Serum Total cholesterol
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
4
Description
Serum triglyceride level (TG)
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
5
Description
Serum high density lipoprotein cholesterol (HDL-C)
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
Using Appropriate kits, by Alpha-Classic autoanalyzer
6
Description
Serum fasting blood sugar(FBS)
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
using Appropriate kits, by Alpha-Classic autoanalyzer
7
Description
Serum low Density Lipoprotein cholesterol (LDL-C)
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
Using Appropriate kits, by Alpha-Classic autoanalyzer
Secondary outcomes
1
Description
visceral fat percent
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
by body Calibrated scale
2
Description
Body fat percent
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
by body Calibrated scale
3
Description
BMI
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
by body Calibrated scale
4
Description
Weight
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
by body Calibrated scale
5
Description
Muscle mass percent
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
by body Calibrated scale
6
Description
evalution of patients diet
Timepoint
Before the intervention and three months after the intervention begin
Method of measurement
Three-day food record
Intervention groups
1
Description
L-carnitine, an oral supplement of 500 mg twice daily for 12 weeks in the intervention group
Category
Treatment - Drugs
2
Description
placebo, 500 mg tablet twice a day for 12 weeks in the placebo group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
dr rahmannian
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid sadughi yazd University of Medical Sciences
Full name of responsible person
Dr hassan mozaffari-khosravi
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid sadughi yazd University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Nasir talenezhad
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8915173160
Phone
00
Fax
Email
n.talenezhad@ssu.ac.ir n.talenezhad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr hassan mozaffari-khosravi
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8915173160
Phone
+98 353538209143
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of nutrition, faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Ir
Full name of responsible person
Nasir talenezahd
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Postal code
Phone
00
Fax
Email
n.talenezhad@ssu.ac.ir n.talenezhad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)