Objectives: we evaluate the effect of verapamil on diabetes in the present study.
Design: Through a placebo-control double blind randomized clinical trial of phase 1, 75 diabetic patients with high blood pressure from three endocrine and heart clinics are selected and classified into three equal groups.
Setting and conduct: Blood fasting sugar and HbA1c and C peptide and insulin are measured by blood test and the results of the beginning and the end of the study are compared.
Participants: Type two diabetic patients with systolic blood pressure greater than 140 and less than 160 mmHg or with diastolic blood pressure greater than 90 mmHg.
Intervention: Intervention group take verapamil and placebo group take amlodipin and control group do not take any kind of drugs for 8 weeks.
Main outcome measures: Primary outcome variables are the changes of fasting blood sugar. Secondary outcome variables are the changes of HbA1c.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100925895N5
Registration date:2016-10-30, 1395/08/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Afsaneh Talaei
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3612
Email address
talaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of verapamil on insulin resistance and fasting blood sugar
Public title
The effect of verapamil on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type two diabetes; systolic blood pressure greater than 140 and less than 160 or diastolic blood pressure greater than 90 mmHg; age between 25-75 years old; intake of any oral drugs of diabetes; HbA1c between 7-8.5%
Exclusion criteria:
Low blood pressure; heart and brain disease; pregnancy; lactation; plan to pregnancy; intake of insulin; drugs such as contraceptive or etrogen or testosterone during past three months; chronic disease such as lung, renal, liver or GI; HbA1c between 7-8.5%; systolic blood pressure greater than 160 mmHg
Age
From 25 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Amialmomenin Hospital, Baseej Square
City
Arak
Postal code
3848176941
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.ARAKMU.REC.1395.146
Health conditions studied
1
Description of health condition studied
Insulin Resistance
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
The changes of insulin resistance
Timepoint
The beginning of the study, After 8 weeks
Method of measurement
Blood examination test
2
Description
The changes of fasting blood sugar
Timepoint
The beginning of the study, After 8 weeks
Method of measurement
Blood examination test
Secondary outcomes
1
Description
The changes of blood pressure
Timepoint
The beginning of the study, After 8 weeks
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: One tab of verapamil, 40 mg, twice a day, oral, for 8 weeks
Category
Treatment - Drugs
2
Description
Placebo group: One tab of amlodipin, 5, mg, once a day, oral, for 8 weeks
Category
Treatment - Drugs
3
Description
Control group: Without usage of any drugs for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Afsaneh Talaei
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafeie
Street address
Arak University of Medical Sciences, Baseej Square
City
Arak
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 Arak 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
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)