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Evaluating the effect of Cabergoline on blood glucose control in type 2 diabetics under treatment with Metformin

Protocol summary

Study aim
Determine the effect of Cabergoline on blood glucose control in type 2 diabetic patients under treatment with Metformin
Design
The patients are divided randomly in two intervention and placebo groups via online software located at www.stat.ubc.ca/Nrollin/stats/ssize/b2.html.
Settings and conduct
Initially, all selected patients will be examined generally and their blood pressure will be controlled. In addition, general characteristics such as age, height, weight as well as initial tests including FBS, 2hPP, HbA1c, Chol-T, TG, HDL, ALT, AST, ... (B-HCG test for women of reproductive age) will be taken. The intervention group will take Cabergolin (produced by Iran hormone company), 0.25 mg twice a week during first 2 weeks and they will take Cabercolin 0.5 mg twice a week for next 12 weeks. The placebo group will take placebo tablets (similar to Cabergoline tablet) through the same protocol as intervention group. After 3 months, the patients will be visited and the tests will be repeated in the same laboratory. During the study, there will be no change in the diet or physical activity of the individuals and the routine treatment will be done for both groups in addition to study intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetic patient with a history of at least 3 months receiving metformin at a dose of 2 g / day; aged 30-65 years; HbA1C levels in the range of 7- 8.5 Exclusion criteria: pregnancy; suffering from other diseases
Intervention groups
The intervention group will take Cabergolin (produced by Iran hormone company), 0.25 mg twice a week during first 2 weeks and they will take Cabercolin 0.5 mg twice a week for next 12 weeks. The placebo group will take placebo tablets (similar to Cabergoline tablet in similar packages) through the same protocol as intervention group.
Main outcome variables
Fast Blood Sugar; 2-hour post prandial glucose; HbA1C

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100314003565N9
Registration date: 2018-06-04, 1397/03/14
Registration timing: registered_while_recruiting

Last update: 2018-06-04, 1397/03/14
Update count: 0
Registration date
2018-06-04, 1397/03/14
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Cabergoline on blood glucose control in type 2 diabetics under treatment with Metformin
Public title
The effect of Cabergoline on blood glucose control in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A type 2 diabetic patient with a history of at least 3 months receiving metformin at a dose of 2 g / day Age from 30 to 65 years HbA1C levels in the range of 7- 8.5 Obtaining Conscious Consent from all Participants involved in the Study
Exclusion criteria:
Pregnancy The presence of other diseases (cardiovascular, kidney, liver, lung, thyroid and pituitary diseases) smoking Taking herbal remedies Taking other diabetes controller drugs
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided in two intervention and placebo groups via online software presents at: www.stat.ubc.ca/Nrollin/stats/ssize/b2.html.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients have no knowledge of the type of the drug (Cabergolin or placebo). The elevator has also no knowledge of the taken drug by patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1291

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Fast blood sugar
Timepoint
Baseline and 3 months after the treatment
Method of measurement
Blood Test

2

Description
2-hour postprandial blood sugar
Timepoint
Baseline and 3 months after the treatment
Method of measurement
Blood Test

3

Description
HbA1C
Timepoint
Baseline and 3 months after the treatment
Method of measurement
Blood Test

Secondary outcomes

1

Description
Cholestrol
Timepoint
Basline and 3 months after the treatment
Method of measurement
Blood Test

2

Description
TG
Timepoint
Basline and 3 months after the treatment
Method of measurement
Blood Test

Intervention groups

1

Description
The intervention group will take Cabergolin (produced by Iran hormone company), 0.25 mg twice a week during first 2 weeks and they will take Cabercolin 0.5 mg twice a week for next 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: The placebo group will take placebo tablets (similar to cabergoline tablets in similar packages) through the same protocol as intervention group .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Dr. Alireza Hadi
Street address
Department of Endocrinology, Imam Reza Hospital, Daneshgah Square, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
Dr.alirezahadi46@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Vice chancellor for Research,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Akbar Aliasgharzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7850
Email
asgharzadeha@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Akbar Aliasgharzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7850
Email
asghrazadeha@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Hadi
Position
Resident of Internal Medicine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Endocrinology, Imam Reza Hospital, Gate University, Tabriz,East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
Dr.alirezahadi46@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after making patiens' data unidentifiable
When the data will become available and for how long
The access period Starts 3 months after publishing the results
To whom data/document is available
All medical doctors and scientific researchers
Under which criteria data/document could be used
merely for other medical studies
From where data/document is obtainable
Dr. Alireza Hadi, Tel: 00989142175242, Email: Dr.alirezahadi46@gmail.com
What processes are involved for a request to access data/document
Initially, the data will be asked by e-mail. If the email is not answered within 10 days, the data should be asked by phone.
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