Comparing the effects of metformin versus Pioglitazone administration on 2 hours plasma ghrelin level in patients with type 2 diabetes referred to diabetes clinic of Imam Khomeini Medical Complex during 2011
In this randomized clinical trial, we will recruit 60 patients with type 2 diabetic aged 30 years old or above. Patients will be chosen from new cases under treatment with diet and exercise or from patients that received only sulfonylurea and have not achieved good control by HbA1c >7% . After signing the informed consent, data including weight, height, waist and blood pressure will be measured for all patients. Patients will be randomly divided to 2 treatment groups: first group will receive metformin and pioglitazone for the second group. Baseline OGTT with 75 gr oral glucose will perform for all patients and blood samples will be collected after 0, 60 and 120 minutes. After treatment for three months, all of the patients will take the second OGTT. As a primary outcome, 2 hours plasma active gherlin after OGTT before and after 3 months treatment we compared between study groups
In this study we examined 2 hours plasma active gherlin after OGTT before and after 3 months treatment with Metformin and pioglitazone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102275917N1
Registration date:2011-05-04, 1390/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-04, 1390/02/14
Registrant information
Name
Hosein Moin Tavakkoli
Name of organization / entity
Endocrine Ward-Valiasr hospital-Tehran university of medical science (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4603
Email address
htavakkoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tehran university of medical science (TUMS)
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of metformin versus Pioglitazone administration on 2 hours plasma ghrelin level in patients with type 2 diabetes referred to diabetes clinic of Imam Khomeini Medical Complex during 2011
Public title
Evaluation of possible cause of weight change after Metformin and pioglitazone administration in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with known type 2 diabetes mellitus more than 30 years
Serum creatinine < 1.5 mg/dl in men and <1.4 mg/dl in women
Exclusion criteria:
Serious cardiovascular diseases
Advanced renal or hepatic diseases
Severe diabetes mellitus complications
Poor compliance
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical science (TUMS)
Street address
TUMS central building, ghods ave. , keshavarz boulevard
City
Tehran
Postal code
Approval date
2011-03-05, 1389/12/14
Ethics committee reference number
130/1577/د/89
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
TypeII Diabetes mellitus
Primary outcomes
1
Description
Plasma ghrelin
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Serum ghrelin measurement after OGTT with 75 gram glucose
Secondary outcomes
1
Description
Leptin
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
2
Description
BMI
Timepoint
Before intervention,3month after intervention
Method of measurement
Weight/(height)2
3
Description
Fasting plasma insulin
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
4
Description
ALT
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
5
Description
Triglyceride
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
6
Description
LDL
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
7
Description
HDL
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
8
Description
Weight
Timepoint
Before intervention,3 month after intervention
Method of measurement
Weight scale
9
Description
Fasting blood sugar
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
10
Description
Blood pressure
Timepoint
Before intervention,3 month after intervention
Method of measurement
Sphygmomanometer
11
Description
HgbA1c
Timepoint
Before intervention,3month after intervention
Method of measurement
Plasma sample
Intervention groups
1
Description
First group: Metformin 500 mg tablet orally bid for 3 month
Category
Treatment - Drugs
2
Description
Second group: Pioglitazone 30 mg tablet orally daily for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic, Imam khomeini medical complex
Full name of responsible person
Dr.Hosein moin tavakkoli
Street address
Imam khomeini medical complex , Bagherkhan ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran university of medical science (TUMS)
Full name of responsible person
Dr. Akbar Fotouhi
Street address
TUMS Central Building, Ghods ave., Keshavarz boulevard
City
Tehran
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, Tehran university of medical science (TUMS)
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
Endocrine ward,Valiasr hospital,TUMS
Full name of responsible person
Dr.Hosein Moin Tavakkoli
Position
Fellowship of Endocrinology
Other areas of specialty/work
Street address
Endocrine ward,Valiasr hospital, Bagherkhan ave.
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2408
Fax
+98 21 6694 8671
Email
htavakkoli@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrine Research center,Valiasr hospital,TUMS
Full name of responsible person
Dr.Alireza Esteghamati
Position
Professor of Endocrine
Other areas of specialty/work
Street address
Endocrine Research center, Valiasr hospital,Bagherkhan ave.
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2408
Fax
Email
Esteghamati@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Endocrine Ward,Valiasr Hospital,TUMS
Full name of responsible person
Dr. Hosein Moin Tavakkoli
Position
Fellowship of Endocrinology
Other areas of specialty/work
Street address
Endocrine Ward,Valiasr Hospital, Bagherkhan ave.
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2373
Fax
Email
htavakkoli@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)