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Effect of Ghrelin on Sympathetic Nervous System

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: NCT00912587
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : November 5, 2018
Information provided by:
Baker Heart and Diabetes Institute

Brief Summary:
Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to stimulate food intake but recent studies indicate that it also acts on the cardiovascular system to confer beneficial effects. The mechanism of action is unclear but experimental studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin injection seems to protect against symptoms of stress. Given that circulating levels of ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and obese subjects.

Condition or disease Intervention/treatment Phase
Healthy Obesity Drug: ghrelin Not Applicable

Detailed Description:
This study will investigate the effect of intravenous administration of ghrelin on blood pressure, heart rate, muscle sympathetic nervous activity and baroreflex control in lean and obese individuals and will investigate whether ghrelin administration can influence the response to stress. Both lean and obese individuals will be recruited and will receive an intravenous administration of ghrelin at increasing doses for 1 hour. Their blood pressure, heart rate and sympathetic activity (small recording electrode in the peroneal nerve) will be recorded and subjects will be submitted to a mental arithmetic stress towards the end of the infusion. Blood samples will be taken at regular intervals for various metabolic tests. These responses will be compared to those when submitted to saline infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Ghrelin on Sympathetic Nervous System and Stress Reactivity
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Intervention Details:
  • Drug: ghrelin
    0.1 microgram/kg/min, intravenous for 60 minutes
    Other Name: Ghrelin (human) acetate

Primary Outcome Measures :
  1. Sympathetic nervous activity [ Time Frame: 60 min ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 60 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy lean subjects with a BMI < 25 kg/m2 and subjects with central obesity (according to IDF definition)

Exclusion Criteria:

  • any current medication
  • a history of diabetes
  • hypertension
  • cardiovascular, cerebrovascular, liver, thyroid disease
  • mental illness

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): NCT00912587

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Australia, Victoria
Alfred & Baker Medical Unit
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker Heart and Diabetes Institute
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Responsible Party: Dr Markus Schlaich, Baker IDI Heart and Diabetes Institute Identifier: NCT00912587    
Other Study ID Numbers: 2009/119
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018