1. Home
  2. Approved trials
  3. » فارسی

The efficacy of bromocriptine for glycemic control in poorly controlled type 2 diabetic patients

Protocol summary

Summary
Type 2 diabetes patients who are uncontrolled (HbA1C between 7.5% and 9%), in spite of maximum dose of metformin and glibenclamide, are entered into the study after notification and their permission. First, patients’ demographic characteristics (age, gender, duration disease, height, weight, abdomen circumference) are determined. Next, base lab tests including, FBS, 2HPPBS, HbA1C, Chol, Tg, HDL are obtained. We start medication with low dose of bromocriptine (1.25 milligram) in bedtime. And, 1.25 milligram of the drug will be added every 3 days (in cases of no complication). We continue this until we reach 2.5 miligram of the drug twice a day. In first visit (1.5 month after starting), FBS, 2HPPBS will be measured. In second and third visit (3 months and 6 months), weight, FBS, 2HPPBS, HbA1C, Chol, Tg, HDL will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204156710N3
Registration date: 2012-05-28, 1391/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-28, 1391/03/08
Registrant information
Name
Mitra Niafar
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
niafarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of medical sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-09-05, 1391/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of bromocriptine for glycemic control in poorly controlled type 2 diabetic patients
Public title
Effect of bromocriptine in diabetes treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All type 2 diabetes patients who do not have exclusion criteria. Exclusion criteria: 1- Age lower than 30 and more than 65; 2- HbA1C lower than 7.5% and more than 9%; 3- Patients who are not willing to participate; 4- Pregnant patients and lactating patients; 5- Syncope attacks; 6- Severe psychosis; 7- Sensitive to bromocriptine and ergot drugs.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Vice chancellor for research of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
917

Health conditions studied

1

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

Primary outcomes

1

Description
Blood sugar
Timepoint
1.5 months
Method of measurement
lab tests

Secondary outcomes

1

Description
Lipid profile
Timepoint
3 and 6 months
Method of measurement
lab tests

Intervention groups

1

Description
We start medication with low dose of bromocriptine (1.25 milligram) in bedtime. And, 1.25 milligram of the drug will be added every 3 days (in cases of no complication). We continue this until we reach 2.5 miligram of the drug twice a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of Tabriz University of medical sciences
Full name of responsible person
Nooshin Milanchan
Street address
Imam Reza and Sina medical centers
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz University of medical sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Tabriz University of Medical sciences, Danshgah street, Goldasht Ave
City
Tabriz
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 Tabriz 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
Medical faculty of Tabriz University of medical sciences
Full name of responsible person
Dr. Nooshin Milanchian
Position
Endocrinology and Metabolism Fellow
Other areas of specialty/work
Street address
Imam Reza hospital, endocrine center
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
noomilan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medicine faculty, Tabriz University of medical sciences
Full name of responsible person
Dr. Nooshin Milanchian
Position
Endocrinology and Metabolism Fellow
Other areas of specialty/work
Street address
Imam Reza hospital, endocrine center
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
noomilan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical faculty of Tabriz University of medical sciences
Full name of responsible person
Nooshin Milanchian
Position
Endocrinology and Metabolism Fellow
Other areas of specialty/work
Street address
Imam Reza hospital, endocrine center
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
noomilan@yahoo.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
Loading...