Postprandial hyperglycemia may lead to progression of atherosclerosis and occurrence of cardiovascular events. An early report showed that vinegar attenuated the glucose and insulin responses to a sucrose or starch load. The aim of this study is to investigate the effect of vinegar on post-prandial blood sugar under treatment of OHA in type 2 diabetes. Our study includes 32 subjects with type 2 diabetes. Subjects provide written informed consent and are taking diabetes medications. Fasting subjects are randomly assigned to consume the vinegar (10 g apple cider vinegar, 40 g water) or placebo(40 g tap water) drink and, after a 2-min delay, the test meal, which is composed of a bread, fresh date , low fat milk , tea (58 g total carbohydrates). The cross-over trial is conducted 1 week later. Blood samples are collected at fasting and 90 min post meal for glucose and insulin analyses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201078630N1
Registration date:2012-02-23, 1390/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-23, 1390/12/04
Registrant information
Name
Zoleyka Moazezi
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8284
Email address
zmoazezi@mubabol.ir.ac
Recruitment status
Recruitment complete
Funding source
vice-chancellor of Research, Babol University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Apple cider Vinegar Effect on Postprandial Glycemia in Patients With Type 2 Diabetes
Public title
Apple cider Vinegar Effect on Postprandial Glycemia in Patients With Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetic patients using oral hypoglycemic agents. Exclusion criteria: using insulin and acarbose; active hyperthyroidism and hypothyroidism; unstable cardiac disease; hospitalized patients.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research, Babol University of Medical Sciences
Street address
Vice-chancellor for research, Daneshgah square, Ganjafrooz avenue
City
Babl
Postal code
4717647754
Approval date
2011-12-31, 1390/10/10
Ethics committee reference number
5337
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
post prandial glycemia
Timepoint
90 min after ingestion of vinegar with breakfast
Method of measurement
glucose oxidase
2
Description
Measurement of postprandial insulin concentration
Timepoint
90 min after ingestion of vinegar with breakfast
Method of measurement
ECL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 g apple cider vinegar + 40 g water with breakfast
Category
Treatment - Drugs
2
Description
Control group: 40 g water with breakfast
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah Rohany Hospital
Full name of responsible person
Hamidreza Nosrati
Street address
Daneshgah Sq., Ganjafrooz St
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Dr. Amrolah Mostafazadeh
Street address
Vice-chancellor for research, Babol University of Medical Sciences
City
Babol
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, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Zoleika Moazezi
Position
Associate professor
Other areas of specialty/work
Street address
Daneshgah Sq., Ganjafrooz St.
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
zmoazezi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Zoleika Moazezi
Position
Associate professor of Babol University of Medical Sciences
Other areas of specialty/work
Street address
Daneshgah Sq., - Ganjafrooz St.
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
zmoazezi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hamidreza Nosrati
Position
MD, Rezident of internal medicine
Other areas of specialty/work
Street address
Daneshgah Sq., Ganjafrooz St.
City
Babol
Postal code
4717647754
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)