B-type Natriuretic Peptide and Glucose Metabolism

NCT01324739 | Completed DMC

• 1 other identifier: OeNB 13583
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus. Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers. Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2 mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1 %BW vs. 11±1, P\<0.002), leading to an overall reduction of glucose concentration (P\<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity. Discussion: Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations after a glucose load without affecting beta cell function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but improves the metabolic status in patients with heart failure. This opens new questions regarding BNP induced differences in glucose availability and signalling in several organs/tissues.

Conditions

Diabetes Mellitus; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• glucose

  0 to 180 minutes

Secondary Outcomes (1)

• insulin, c-peptide

  0 to 180 minutes

Study Arms (2)

B-type natriuretic peptide

ACTIVE COMPARATOR

the effect of B-type natriuretic peptide on glucose metabolism will be compared with placebo during an intravenous glocose tolerance test

Drug: human BNP-32

Placebo

PLACEBO COMPARATOR

comparison of the effect of b-type natriuretic peptide on glucose metabolism and placebo

Drug: human BNP-32

Interventions

human BNP-32 DRUG

3pmol/kg/min infusion

Also known as: human b-type natriuretic peptide

B-type natriuretic peptide; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent no disease history BNP level within the normal range Normal renal function (serum creatinine of more than 1.3 mg/dL and/or creatinin clearance greater than 80ml/min) Normal ECG

You may not qualify if:

• systolic blood pressure \< 90 mmHg subjects on any medication abnormal glucose metabolism history of anaphylaxis

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Heinisch BB, Vila G, Resl M, Riedl M, Dieplinger B, Mueller T, Luger A, Pacini G, Clodi M. B-type natriuretic peptide (BNP) affects the initial response to intravenous glucose: a randomised placebo-controlled cross-over study in healthy men. Diabetologia. 2012 May;55(5):1400-5. doi: 10.1007/s00125-011-2392-1. Epub 2011 Dec 13.

  PMID: 22159910 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Cardiomyopathies

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Martin Clodi, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 29, 2011

Record last verified: 2010-10

Locations

AU (1)