Protocol summary

Summary
Obesity and diabetes are two important health problems in the world. There is relationship between obesity and diabetes, probability of diabetes and metabolic syndrome in obese people, are more likely to occur. Diabetes and obesity are associated with such frequency that it has been proposed for the term Diabesity. So, decrease in adipose tissue could lead to a reduction in inflammatory markers, components of metabolic syndrome and increased insulin sensitivity is improved. In this double blind clinical trial we aim to achieve new approach for prevent and combat obesity and diabetes, sixty non pregnant or lactating premenopausal obese women aged 18 -48 years, with type 2 diabetes attending the ِِDiabetes Clinic of Tabriz Red Crescent, who have not participated in weight-reduction programs during last 6 months, will be enrolled. Patients who don't follow the prescribed diet or using insulin and special diet or drugs or supplementes (such as vitamin B6, C ) will be excluded from the study. Volunteers will be randomly allocated into two groups for 8 weeks intervention: Carnitine (1 gr, twice daily), with hypo caloric diet as an intervention group and placebo with hypo caloric diet as a control group. Inflammatory indicators (hs-CRP, IL-6), metabolic status (fasting blood sugar, insulin resistance, lipid profile), leptin, visfatin, anthropometric indicators and Body Fat mass will be measured at baseline and endpoint of study and will be analyzed statistically.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903164105N1
Registration date: 2011-12-10, 1390/09/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-10, 1390/09/19
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-carnitine supplementation on metabolic status,leptin and visfatin adipokines in obese diabetic women with hypocaloric diet
Public title
Effect of L-carnitine supplementation on metabolic status,leptin and visfatin adipokines in obese diabetic women with hypocaloric diet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obese women with type2 diabetic; age range 18 to 48years; no cancer, liver or renal disease; receiving any therapeutic diet except diabetes diet; no Pregnancy, lactation and menopause of women. Exclusion criteria: Consumption of any food supplement or drug which influence carnitine or lipid profile (such as vitamin B6 - C ); treatment with insulin and Failure to follow the prescribed diet.
Age
From 18 years old to 48 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht ST,Tabriz +00984113357313
City
Tabriz
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
5876/4/5

Health conditions studied

1

Description of health condition studied
Diabetic
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

2

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
obesity

Primary outcomes

1

Description
leptin
Timepoint
baseline, endpoint
Method of measurement
Elisa

2

Description
visfatin
Timepoint
baseline, endpoint
Method of measurement
Elisa

3

Description
Anthropometric indicators: weight, body mass index, waist circumference, hip circumference and waist to hip ratio
Timepoint
baseline, endpoint
Method of measurement
Standard procedures using scale, tape and equations

4

Description
Body Fat Mass
Timepoint
baseline, endpoint
Method of measurement
Bioimpedance

Secondary outcomes

1

Description
FBS
Timepoint
baseline, endpoint
Method of measurement
autoanalyzer

2

Description
Insulin resistance: Insulin, HOMA-IR index
Timepoint
baseline, endpoint
Method of measurement
Elisa and formula

3

Description
IL-6, hs-CRP
Timepoint
baseline, endpoint
Method of measurement
Elisa and autoanalyzer

4

Description
TG
Timepoint
baseline, endpoint
Method of measurement
autoanalyzer

5

Description
cholesterol
Timepoint
baseline, endpoint
Method of measurement
autoanalyzer

6

Description
HDL
Timepoint
baseline, endpoint
Method of measurement
autoanalyzer

7

Description
blood pressure
Timepoint
baseline, endpoint
Method of measurement
sphygmomanometer

Intervention groups

1

Description
Intervention groups: 1 gr of carnitine tablet twice a day with hypocaloric diet (500 kcal less than patients's energy requirementes )
Category
Treatment - Drugs

2

Description
Control groups: 1 gr of placebo twice a day with hypocaloric diet (500 kcal less than patients's energy requirementes )
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Tabriz Red Crescent
Full name of responsible person
Ali Barzegar
Street address
Tabriz Red Crescent, Abrasan Ave, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi, Dr.Alireza Ostadrahimia
Street address
Tabriz University of Medical Sciences, Golgasht ST,Tabriz +00984113357313
City
Tabriz
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, Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health and Nutrition, Tabriz university of Mdical Sciences
Full name of responsible person
Dr. Beit Allah Alipour
Position
Assistant Professor of Nutrition, in School of Health and Nutrition
Other areas of specialty/work
Street address
School of Health and Nutrition, Attar-e Nishaboori ST, Golgasht ST, Tabriz,+984113357580-4,balipoor@yahoo.com
City
Tabriz
Postal code
Phone
+98 914 415 7042
Fax
Email
balipoor@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health and Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Ph.D student in Nutrition
Other areas of specialty/work
Street address
School of Health and Nutrition, Attar-e Neishaboori ST, Tabriz, +00984113357580-4
City
Tabriz
Postal code
Phone
Fax
Email
alibarzegar@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...