Protocol summary

Summary
Objectives: To investigate the role of an alternative carbohydrate diet on glycemic control, we intend to explore the effect of a low glycemic load (Low GL)-high fat diet on glycemic response and also glycated hemoglobin (HbA1c) of poor-controlled diabetes patients. Design: The project is "before and after" study in one group and each subject is him/her control. Inclusive and exclusive criteria: The inclusive criteria are: men and women with age of 30-60 years, BMI> 25, HbA1c > 8% and the exclusive criteria includes: patients having renal, heart, gastro-intestinal disorders, chronic disease, pregnant and nursing mothers. Setting and conduct: Hundred poorly-controlled diabetes patients, HbA1c > 8% who are referred to endocrine clinic in city of Qazvin and are consuming traditional medium carbohydrate diabetic diet will be recruited for the study. Fasting blood samples for biochemical analysis will be taken and weight and BMI will be recorded at the beginning and after a-10 week diet intervention. Patients will have their routine life style program during intervention. The mean of the data before and after intervention will be compared using paired t-test Intervention: A low GL diet (Energy 1800-2200 kcal; total fat 36%; fat derived from olive oil and nuts 15%; carbohydrate 42%; protein 22%) will be administrated to patients for 10 weeks Main outcome measures: Fasting blood glucose, HbA1c, triglyceride, cholesterol (LDL, HDL), Body weight, and BMI changes of patients will be measured, comparing related data of before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110057724N1
Registration date: 2012-06-20, 1391/03/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-20, 1391/03/31
Registrant information
Name
Ahmad Afaghi
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
aafaghi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the low glycemic index-low glycemic load diet on HbA1c of Poor-Controlled over weight Type 2 Diabetics
Public title
Effect of the low glycemic index-low glycemic load diet on HbA1c of Poor-Controlled over weight Type 2 Diabetics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male and female patients with type 2 diabetic in age range of 30-60 (years) with HbA1c > 8% , BMI> 25 Exclusion criteria: Patients with renal; cardial and digestional and other chronic diseases; Patients with metabolic diseases (except for diabetic); Pregnant and nursing women
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences Ethic Committee
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Postal code
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
د/20/3052

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type II Diabetes

Primary outcomes

1

Description
FBS
Timepoint
before and after 10 weeks intervention
Method of measurement
labratory biochemical measurement

2

Description
HbA1c
Timepoint
before and after10 weeks intervention
Method of measurement
labratory biochemical measurement

3

Description
Weight
Timepoint
before and after10 weeks intervention
Method of measurement
scale

4

Description
Tri glyceride and Cholesterol
Timepoint
before and after10 weeks intervention
Method of measurement
labratory biochemical measurement

Secondary outcomes

empty

Intervention groups

1

Description
patients were treated with low glycemic load diet for 10 weeks.
Category
Treatment - Drugs

2

Description
before and after
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Booali Hospital
Full name of responsible person
Ahmad Afaghi
Street address
Boo-Ali Hospital, Boo-Ali St., Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Saeed Asefzadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
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, Qazvin 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
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Ahmad Afaghi
Position
Director of Social Medicine, PhD Nutrition
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aafaghi@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Ahmad Afaghi
Position
Director of Social Medicine, PhD Nutrition
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aafaghi@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Ahmad Afaghi
Position
Director of Social Medicine, PhD Nutrition
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
aafaghi@qums.ac.ir
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...