Protocol summary

Summary
Drug-induced hypoglycemia is a major obstacle for individuals with type 1 and type 2 diabetes trying to achieve glycemic targets. The episodes of hypoglycemia may increase cardiovascular mortality among patients with or without underlying heart disease. The mechanisms by which hypoglycemia cause increased cardiovascular risk are not clear and are under debate. According to some studies, hyperglycemia increase blood homocysteine and C-reactive protein (CRP) levels as the predisposing factors of cardiovascular disease. However, the effect of hypoglycemia on the level of CRP and homocysteine markers has not been clarified. To determine whether the episodes of hypoglycemia are likely to be associated with cardiovascular disease by increasing blood CRP and homocysteine concentrations, we carried out a study to evaluate blood levels of these two factors in response to insulin-induced hypoglycemic stress. In this regard, fifteen non-diabetic healthy male individuals were enrolled for the study. In all subjects, hypoglycemia was induced by the injection of 0.1 to 0.15 unit/kg intravenous regular insulin. When a blood glucose level dropped below 45 mg/dl, hypoglycemia would be defined to be present. Blood samples were taken from a dedicated intravenous line before the start of test and serially after the injection of insulin in divided times and for 240 minutes. Counter regulatory hormone levels (growth hormone, cortisol, norepinephrine, epinephrine, ACTH), homocysteine, and CRP would be checked at baseline and 30, 45, 60, 120, 240 minutes after insulin injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811112587N3
Registration date: 2010-06-01, 1389/03/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-01, 1389/03/11
Registrant information
Name
Parviz Hosseini
Name of organization / entity
Parsroos Company
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 0763
Email address
dr.p.hosseini@gmail.com
Recruitment status
Recruitment complete
Funding source
Endocrinology and Metabolism Research Center
Expected recruitment start date
2008-10-01, 1387/07/10
Expected recruitment end date
2008-12-01, 1387/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Homocysteine,C-reactive protein, and counter regulatory hormone changes in insulin-induced hypoglycemia.
Public title
Cardiovascular side effects of hypoglycemia
Purpose
Other
Inclusion/Exclusion criteria
Inclusions Criteria: age 18–65 years, healthy individuals according to clinical and paraclinical assessments, BMI range of 19-30 kg/m2, written informed consent. Exclusions Criteria: anemia (hematocrit <30%), history of smoking, chronic disease, (i.e. chronic liver disease, renal insufficiency (creatinin > 1.5 mg/dl), and cardiovascular disease), central nervous system diseases including seizure disorder, defined diabetes mellitus, hypertension, concurrent infection, and fasting blood glucose≥126 mg/dl.
Age
From 19 years old to 40 years old
Gender
Male
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
Endocrinology and Metabolism Research Center ethics committee
Street address
Shariati Hospital, North Kargar Ave, Tehran 14114, Iran
City
Tehran
Postal code
Approval date
2008-09-28, 1387/07/07
Ethics committee reference number
E-0068

Health conditions studied

1

Description of health condition studied
Homocystein, CRP and counter regulatory hormones evaluations in response to hypoglycemia
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Serum homocystein level
Timepoint
Baseline, and 30, 45, 60, 120, 240 after insulin injection
Method of measurement
Plasma HPLC

2

Description
Serum CRP level
Timepoint
Baseline, and 30, 45, 60, 120, 240 after insulin injection
Method of measurement
Plasma HPLC

Secondary outcomes

1

Description
Blood Growth Hormone Level
Timepoint
Baseline, and 30, 45, 60, 120, 240 minutes after insulin injection
Method of measurement
Plasma HPLC

2

Description
Serum Cortisol
Timepoint
Baseline, and 30, 45, 60, 120, 240 minutes after insulin injection
Method of measurement
Plasma HPLC

3

Description
Serum norepinephrine level
Timepoint
Baseline, and 30, 45, 60, 120, 240 minutes after insulin injection
Method of measurement
Plasma HPLC

4

Description
Serum epinephrine level
Timepoint
Baseline, and 30, 45, 60, 120, 240 minutes after insulin injection
Method of measurement
Plasma HPLC

5

Description
Serum ACTH level
Timepoint
Baseline, and 30, 45, 60, 120, 240 minutes after insulin injection
Method of measurement
Plasma HPLC

Intervention groups

1

Description
Intravenous regular insulin 0.1-0.15 Unit/Kg
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Center
Full name of responsible person
Dr. Ramin Heshmat
Street address
5th floor, Shariati Hospital, North Kargar Ave, Tehran 14114, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Center
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
Endocrinology and Metabolism Research Center
Full name of responsible person
Dr. Ramin Heshmat
Position
vice-chancellor/MD,PhD
Other areas of specialty/work
Street address
5th Floor, Shariati Hospital, North Kargar Ave., Tehran 14114, Iran
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
emrc@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrinology and Metabolism Research Center
Full name of responsible person
Dr. Bagher Larijani
Position
Chancellor of Tehran University of Medical Scieces/MD(Endocrinologist)
Other areas of specialty/work
Street address
5th floor, Shariati Hospital, North Kargar Ave., Tehran 14114, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
emrc@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Parviz Hosseini
Position
MD
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
dr.p.hosseini@gmail.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
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