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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459511
Recruitment Status : Completed
First Posted : April 12, 2007
Last Update Posted : April 12, 2007
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo

Brief Summary:

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 or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Hyperglycemia Procedure: Blood AM, IL-6, ACTH, Cortisol, Glucose and Insulin

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.

Study Type : Observational
Enrollment : 20 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Importance of Adrenomedullin (AM) on Pituitary-Adrenal Axis and Glucose Kinetics in Pediatric Patients With Systemic Inflammatory Response Syndrome
Study Start Date : January 2006
Actual Study Completion Date : October 2006

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459511

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

Publications of Results: Identifier: NCT00459511     History of Changes
Other Study ID Numbers: FMUSP/ cappesq 675/05
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: April 12, 2007
Last Verified: April 2007

Keywords provided by University of Sao Paulo:
Systemic Inflammatory response Syndrome

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents