OBJECTIVE: The effect of a single 8 mg oral dose of dexamethasone versus placebo on glucose homeostasis, insulin homeostasis, insulin secretion and resistance indices, during oral glucose tolerance test, performed before and 24 hours after dexamethasone.
Inclusion criteria: 20-65 years old individuals ؛ first-degree relative with type 2 diabetic patients
Exclusion criteria: corneal wound infection ؛ active liver disease ؛ pregnancy ؛ use of corticosteroids ؛ use of thiazide
Volume of the sample: 44 individuals with normal oral glucose tolerance test؛
43 individuals with pre-diabetes.
The intervention: The effect of a single 8 mg oral dose of dexamethasone, on oral glucose tolerance test.
The time of intervention: The second day
The primary outcome measurement: The plasma glucose and insulin measurment in 0, 30, 60 and 120 minutes during oral glucose tolerance test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111308258N1
Registration date:2011-12-26, 1390/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Nader Taheri
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9933
Email address
emrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences,
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexamethasone on glucose homeostasis in normal and prediabetic individuals with a first-degree relative with type 2 diabetes
Public title
Dexamethasone effect on oral glucose tolerance test
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:20-65 years old individuals with first degree relative of diabetic patients
Exclusion criteria: Active peptic ulcer؛ active herpetic corneal ulcer؛ psychosis؛ positive pregnancy test؛ current use of oral contraceptives in women and thiazide or glucocorticoids use in any person
Age
From 20 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
98
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
Isfahan Endocrine and metabolism Research Center Ethics Committee
Street address
sedigheh tahereh Medical Research Complex,Khorram Street,Isfahan,Iran
City
Isfahan
Postal code
8187698191
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
389003
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Plasma insulin in 0,30,60,120 minutes during OGTT
Timepoint
first day and second day
Method of measurement
pmol/l
2
Description
Plasma glucose in 0,30,60,120 minutes durig OGTT
Timepoint
first day and second day
Method of measurement
mmol/l
Secondary outcomes
1
Description
AUC(g)=Area under the curve of glucose
Timepoint
first day and second day
Method of measurement
By related formulae
2
Description
AUC(i)= Area under the curve of insulin
Timepoint
first day and second day
Method of measurement
By related formulae
3
Description
AUC(i) / AUC(g)
Timepoint
first day and second day
Method of measurement
By related formulae
4
Description
HOMA-IR index
Timepoint
first day and second day
Method of measurement
By related formula
5
Description
Homa-B index
Timepoint
first day and second day
Method of measurement
By related formulae
6
Description
Matsuda index
Timepoint
first day and second day
Method of measurement
By related formulae
7
Description
Insulinogenic index
Timepoint
first day and second day
Method of measurement
By related formulae
8
Description
Disposition index
Timepoint
first day and second day
Method of measurement
By related formulae
Intervention groups
1
Description
A single oral 8 mg placebo tablet
one time
First day
Category
Placebo
2
Description
A single oral 8 mg dexamethasone tablet
one time
first day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Dr. Nader Taheri
Street address
Sedigheh Tahereh Medical research complex, Khorram Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Massoud Amini
Street address
Sedigheh Tahereh Medical Research Complex, Khorram street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan Endocrine and metabolism research center
Full name of responsible person
Dr. Massoud Amini
Position
Director
Other areas of specialty/work
Street address
Sedigheh Tahereh Medical Research Complex, Khorram Street
City
Isfahan
Postal code
8187698191
Phone
+98 31 1335 9933
Fax
Email
emrc@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Dr. Massoud Amini
Position
Director and internist
Other areas of specialty/work
Street address
Sedigheh Tahereh Medical Research Complex, Khorram Street
City
Isfahan
Postal code
8187698191
Phone
+98 31 1335 9933
Fax
Email
emrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Dr. Nader-Taheri
Position
Endocrinologist
Other areas of specialty/work
Street address
Sedigheh Tahereh Medical Research Complex, Khorram street,
City
Isfahan
Postal code
8187698191
Phone
+98 31 1335 9933
Fax
Email
nader_taheri2002@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)