Bromocriptine effect on left ventricular hypertrophy in patients with diabetic nephropathy

Phase 4

Completed

• Conditions: eft ventricular hypertrophy; Type 2 diabetes mellitus (DM2); Stage IV of chronic kidney disease; Left ventricular hypertrophy; Metabolic and Endocrine - Diabetes; Cardiovascular - Coronary heart disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000779077
• Lead Sponsor: Escuela Superior de Medicina del Instituto Politecnico Nacional (IPN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Patients treated with dopamine (DA2) receptors antagonists.

Cardiac insuficiency.

Cardiac stroke.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Baseline, three and six months following randomisation];Systolic, diastolic and mean blood pressured assesed by 24h ambulatory blood pressure, using a 24 h ambulatory non invasive device.[Baseline, three and six months after randomisation]

Secondary Outcome Measures

Name	Time	Method
24h creatinine clearance. assessed in a 24h urine sample and blood sample.[Baseline, three and six months after randomization];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.[Baseline, three and six months after randomization];Prolactin plasma levels determined in blood samples[Baseline and three and six months following randomization]