The study was a single-arm clinical trial. Participants were 15 patients with type 2 diabetes (5 males and 10 females) whose HbA1c was <7% and used metformin as the controlling agent. Experiments were performed on 3 separate days, each day with one type of snack. At least one week was set between experiments. Each experimental day, fasting blood glucose was initially measured. Then, an equal amount of breakfast was given to the participants and 2 hours later blood glucose was measured again. Afterwards, the patients consumed a snack, which contained 15 grams of available carbohydrate (i.e. tea with dates, tea with raisins, or tea with sugar) and their postprandial blood glucose was measured at 30, 60, and 120 minutes. Blood glucose was measured using a glucometer and each measurement was performed in duplicate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112920140N1
Registration date:2015-01-03, 1393/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Sahar Foshati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71372510015
Email address
foshatis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of consuming dates, raisins, and sugar on blood glucose in patients with type 2 diabetes
Public title
Comparing the effect of consuming dates, raisins, and sugar on blood glucose in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from diabetes mellitus type 2 (FPG ≥ 126 mg/dl), diabetes record of less than 10 years, taking metformin for the control of diabetes, glycosylated hemoglobin (HbA1c) less than 7%, and willingness to participate in the study. Exclusion criteria: morbid obesity (BMI ≥40 kg/m2), pregnancy, alcohol consumption, smoking, use of steroidal drugs such as prednisolone, recent use of antibiotics, taking levothyroxine, stress or severe pain, heart attack in the prior 6 months, severe gastrointestinal disorders, gastrointestinal surgery, a history of gastroenteritis in the prior 6 months, severe liver or kidney failure and cancer.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Medical Sciences University, Zand Avenue
City
Shiraz
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
CT-P-9362-6712
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Blood glucose
Timepoint
Fasting, 2 hours after consuming breakfast, and 30, 60 and 120 minutes after consuming snack in every three day of study
Method of measurement
Using the Glucocard 01 glucometer
Secondary outcomes
empty
Intervention groups
1
Description
Snacks: 150 ml tea + dates, raisins, or sugar (each one contained 15 grams of available carbohydrate). The intervention was performed on three separate days, each day with one of the aforementioned snacks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Fatemeh Alzahra Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Mr. Kambiz Eskandari
Street address
Central Building of Medical Sciences University, Zand Avenue
City
Shiraz
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 Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sahar Foshati
Position
Postgraduate student of nutrition sciences
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71372510015
Fax
Email
foshatis@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Akhlaghi
Position
Assistant professor - Faculty member
Other areas of specialty/work
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71372510015
Fax
Email
akhlaghi_m@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)