Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000779077
Ethics application status
Approved
Date submitted
12/09/2010
Date registered
20/09/2010
Date last updated
20/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bromocriptine effect on left ventricular hypertrophy in patients with diabetic nephropathy
Scientific title
Bromocriptine effect on left ventricular hypertrophy in patients with diabetic nephropathy
Secondary ID [1] 1006 0
Cochrane Renal Group: CRG020600041
Universal Trial Number (UTN)
Trial acronym
BELVHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left ventricular hypertrophy 243722 0
Type 2 diabetes mellitus (DM2) 258206 0
Stage IV of chronic kidney disease 258208 0
Condition category
Condition code
Metabolic and Endocrine 252108 252108 0 0
Diabetes
Cardiovascular 258380 258380 0 0
Coronary heart disease
Renal and Urogenital 258381 258381 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bromocriptine oral tablets 2.5 mg or bromocriptine placebo oral tablets 2.5 mg . The daily doses administered were as follows: Week 1: 1x2.5 mg oral tablet per day, taken after the night meal;Week 2: 2 x 2.5 mg oral tablets per day (5 mg), taken in the morning meal and after the night meal; Weeks 3 - 24 : 3 x 2.5 mg oral tablets per day (7.5 mg) taken after meals. The subjects received this medication in addition to their current treatment.
Intervention code [1] 241346 0
Treatment: Drugs
Comparator / control treatment
The placebo oral tablets looks like the bromocriptine tablets, same color, size and appearance, but made of starch.
Control group
Placebo

Outcomes
Primary outcome [1] 240790 0
Changes in left ventricular hypertrophy, assessed by two dimensionally guided M-mode echocardiography). This study was done by an expert who didn't know the treatment of the patients, and he followed the recomendations of the American Society of Cardiology. The measures assesed were: left ventricular mass, left ventricular posterior wall thikness, left ventricular septum thikness, left ventricular diastolic diameter and left ventricular mass index that was calculated according with Devereux formula.
Timepoint [1] 240790 0
Baseline, three and six months following randomisation
Primary outcome [2] 252987 0
Systolic, diastolic and mean blood pressured assesed by 24h ambulatory blood pressure, using a 24 h ambulatory non invasive device.
Timepoint [2] 252987 0
Baseline, three and six months after randomisation
Secondary outcome [1] 257754 0
24h creatinine clearance. assessed in a 24h urine sample and blood sample.
Timepoint [1] 257754 0
Baseline, three and six months after randomization
Secondary outcome [2] 257755 0
Pro brain natriuretic peptide,determined in blood sample after a fasting period of 10 h. the samples were obtained after 30 minutes resting in bed.
Timepoint [2] 257755 0
Baseline, three and six months after randomization
Secondary outcome [3] 265629 0
Prolactin plasma levels determined in blood samples
Timepoint [3] 265629 0
Baseline and three and six months following randomization

Eligibility
Key inclusion criteria
type 2 diabetes mellitus
Left ventricular mass > or = 116 g/m2in men and 104 g/m2 in women.
Creatinine clearance < or =30 ml/min.
24h Ambulatory blood pressure (AMBP) > or = 130/80 mmHg.
Patients who give written informed consent
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients treated with dopamine (DA2) receptors antagonists.

Cardiac insuficiency.

Cardiac stroke.

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)
Subjects were randomised through table of random numbers by permuted block randomization, that were saved in opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A table of random numbers were used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2043 0
Mexico
State/province [1] 2043 0
Michoacan

Funding & Sponsors
Funding source category [1] 243802 0
Charities/Societies/Foundations
Name [1] 243802 0
Fondo de Fomento a la Investigacion del Instituto mexicano del Seguro Social
Country [1] 243802 0
Mexico
Primary sponsor type
University
Name
Escuela Superior de Medicina del Instituto Politecnico Nacional (IPN)
Address
Plan de San Luis y Diaz Miron.
Mexico D.F. C.P. 11340
Country
Mexico
Secondary sponsor category [1] 237151 0
Hospital
Name [1] 237151 0
Unidad de Medicna Familiar No 80 del Instituto Mexicano del Seguro Social (IMSS)
Address [1] 237151 0
Ave Madero poniente 1200. Colonia Centro
Morelia, Michoacan, C.P. 58000
Country [1] 237151 0
Mexico
Secondary sponsor category [2] 237154 0
Hospital
Name [2] 237154 0
Hospital General Regional No 1/ Unidad de Medicina Familiar No 80 del Instituto Mexicano del Seguro Social
Address [2] 237154 0
Ave Heroes de Nocupetaro S/N
Morelia, Michoacan . CP. 58010
Mexico
Country [2] 237154 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259686 0
Comite Local de Investigacion No 1602
Ethics committee address [1] 259686 0
Ethics committee country [1] 259686 0
Mexico
Date submitted for ethics approval [1] 259686 0
02/09/2003
Approval date [1] 259686 0
23/10/2003
Ethics approval number [1] 259686 0
2003.296.00016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30175 0
Address 30175 0
Country 30175 0
Phone 30175 0
Fax 30175 0
Email 30175 0
Contact person for public queries
Name 13422 0
Dr, Ramon Paniagua-Sierra
Address 13422 0
Unidad de Investigacion en Enfermedades Nefrologicas
Centro Medico Nacional Siglo XXI. IMSS
Ave Cuauhtemoc No 330
Col. Doctores
México DF. C.P. 06725
Country 13422 0
Mexico
Phone 13422 0
52 55 57 52 59 67 ext 21371
Fax 13422 0
Email 13422 0
[email protected]
Contact person for scientific queries
Name 4350 0
Dr, Oliva, Mejia-Rodriguez
Address 4350 0
Instituto Mexicano del Seguro Social
Unidad de Medicina Familiar No 80
Avenida Madero poniente No 1200
Morelia, Michoacan
C.P. 58000
Country 4350 0
Mexico
Phone 4350 0
52 443 3 12 28 80 ext 31407
Fax 4350 0
52 443 3 13 70 26
Email 4350 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
Dimensions AICardiovascular and Renal Effects of Bromocriptine in Diabetic Patients with Stage 4 Chronic Kidney Disease2013https://doi.org/10.1155/2013/104059
N.B. These documents automatically identified may not have been verified by the study sponsor.