The Importance of Adrenomedullin (AM) on ACTH-Cortisol-Glucose Axis

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00459511
First received: April 11, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

Hyperglycemia is frequent manifestations of the human metabolic response to systemic inflammatory response syndrome (SIRS),sepsis and septic shock, and are implicated in the clinical outcome.

Adrenomedullin is elevated in SIRS, sepsis and septic shock and has been demonstrated the inhibitory role on insulin and adrenocorticotropic hormone secretion.

Our hypothesis is that: AM elevation after SIRS could be the responsible to maintain hyperglycemia


Condition Intervention Phase
Systemic Inflammatory Response Syndrome
Hyperglycemia
Procedure: Blood AM, IL-6, ACTH, Cortisol, Glucose and Insulin
Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: The Importance of Adrenomedullin (AM) on Pituitary-Adrenal Axis and Glucose Kinetics in Pediatric Patients With Systemic Inflammatory Response Syndrome

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 20
Study Start Date: January 2006
Study Completion Date: October 2006
Detailed Description:

Studies in cultured vascular endothelial cells and vascular smooth muscle cells demonstrate that cytokines strongly stimulate adrenomedullin production and release.

Adrenomedullin has been measured in a wide range of clinical researches. Of all conditions investigated, the greatest increment in plasma adrenomedullin has been observed in septic shock. It appears that AM is directly responsible for the hypotension characteristic of septic shock. Studies have shown that administration of AM and AMBP-1 before the onset of sepsis (i.e., pretreatment) prevents transition from the hyperdynamic phase to the hypodynamic phase in the progression of sepsis, attenuates tissue and organ damage, and reduces sepsis-induced mortality.

Two groups described the effects of AM on the pituitary. Taken together, these studies suggest that AM has a role in inhibiting ACTH release.

Mulder et al. first reported the stimulatory effects of adrenomedullin on insulin secretion from isolated rat islets. In direct contrast to this, Martínez et al. clearly demonstrated the inhibitory role of adrenomedullin on insulin secretion in vitro.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children above 2 years, submitted to elective cardiopulmonary bypass (CPB, only interatrial or ventricular communication) with no endocrine disease or infection.

Exclusion Criteria:

  • Children with endocrine disease, undernutrition, with some medication that might interfere in the study (corticosteroids.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00459511

Locations
Brazil
Childrens Institute
Sao Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Thelma Okay, PHD Childrens Institute / Molecular Biology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00459511     History of Changes
Other Study ID Numbers: FMUSP/ cappesq 675/05
Study First Received: April 11, 2007
Last Updated: April 11, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Adrenomedullin
Glucose
Insulin
Systemic Inflammatory response Syndrome
Pediatric
Cortisol
ACTH

Additional relevant MeSH terms:
Hyperglycemia
Systemic Inflammatory Response Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Inflammation
Pathologic Processes
Shock
Adrenocorticotropic Hormone
Insulin
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Adrenomedullin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents
Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014