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Trial registered on ANZCTR


Registration number
ACTRN12613001121752
Ethics application status
Approved
Date submitted
20/09/2013
Date registered
8/10/2013
Date last updated
8/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Cabergoline on biochemical and anthropometric parameters of patient with Impaired Glucose metabolism (Impaired Fasting Glucose/Impaired Glucose Tolerance)
Scientific title
Effect of Cabergoline Vs placebo on HbA1C, HOMA-IR, HOMA-Beta, FPG, anthropometric parameters in patient with Impaired fasting glucose/Impaired glucose tolerance.
Secondary ID [1] 283265 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 290137 0
Condition category
Condition code
Metabolic and Endocrine 290526 290526 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
addition of Cabergoline 0.5 mg oral tabletes twice weekly for 4 month or placebo in patients with prediabetes receiving a balanced diet, to to measure patient compliance to Cabergoline, tablet returned counted at the final visit, in addition to comparing thr prolactin level of every patient.
Intervention code [1] 287992 0
Treatment: Drugs
Comparator / control treatment
Placebo contains lactose and other excipient of Cabergoline tabletes
Control group
Placebo

Outcomes
Primary outcome [1] 290552 0
reversal of insulin resistance based on HOMA-IR Model.
HOMA-IR will be calculated, using a fasting plasma sample, insulin level, and was derived by use of the insulin-glucose product, divided by a constant (405 when using mg/dL and 22.5 when using mmol/L for FPG reporting)
Timepoint [1] 290552 0
4 months
Primary outcome [2] 290665 0
Improving Insulin secretion based on HOMA-Beta model.
HOMA-Beta will be calculated as HOMA-IR.
Timepoint [2] 290665 0
4 month
Secondary outcome [1] 304778 0
alleviation of HbA1C level
HbA1C measured using enzymatic method and high-performance liquid chromatography (HPLC)
Timepoint [1] 304778 0
4 month

Eligibility
Key inclusion criteria
Fasting Plasma Glucose (FPG): 100-110 mg/dL or/and 2 hour Plasma Glucose after Oral Glucose Tolerance Test (2hPG): 140-199 mg/dL.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) severe hepatic failure (Child-Pugh scores of 10 or higher)
2) history of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders; increased risk of pleural effusion/pulmonary fibrosis
3) hypersensitivity to ergot derivatives
4) uncontrolled hypertension
5) Diabetes
6) Pregnant Women
7) Lactating Women
8) Major psychiatric disorders
9) Recieving Medication effect prolactin secretion
10) Bulimia or/and anorexia nervosa

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
30/10/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5432 0
Iran, Islamic Republic Of
State/province [1] 5432 0
Tehran

Funding & Sponsors
Funding source category [1] 288005 0
University
Name [1] 288005 0
Shahid Beheshti University of Medical Sciences
Country [1] 288005 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of Medical Sciences
Address
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran PO box: 14397-65461
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286727 0
None
Name [1] 286727 0
Address [1] 286727 0
Country [1] 286727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289928 0
Ethics commiittee, Shahid Beheshti University of Medical sciences
Ethics committee address [1] 289928 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran PO box: 14397-65462
Ethics committee country [1] 289928 0
Date submitted for ethics approval [1] 289928 0
02/02/2013
Approval date [1] 289928 0
01/03/2013
Ethics approval number [1] 289928 0

Summary
Brief summary
Impaired Glucose metabolism has no treatment and only life style modification could stop progression of this condition to diabetes, so we want to try effect of cabergoline in this condition to alleviate metabolic impairment and progression to diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43122 0
Dr Mohammad Abbasinazari
Address 43122 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 43122 0
Iran, Islamic Republic Of
Phone 43122 0
+98 2188873704
Fax 43122 0
Email 43122 0
[email protected]
Contact person for public queries
Name 43123 0
Hadi Esmaily
Address 43123 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 43123 0
Iran, Islamic Republic Of
Phone 43123 0
+98 2188873704
Fax 43123 0
Email 43123 0
[email protected]
Contact person for scientific queries
Name 43124 0
Hadi Esmaily
Address 43124 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 43124 0
Iran, Islamic Republic Of
Phone 43124 0
+98 2188873704
Fax 43124 0
Email 43124 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes twice-weekly cabergoline improve anthropometrical and biochemical profiles in prediabetes? A randomized double-blind clinical trial pilot study.2015
N.B. These documents automatically identified may not have been verified by the study sponsor.