Effect of Ghrelin on Sympathetic Nervous System

This study has been completed.
Sponsor:
Information provided by:
Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier:
NCT00912587
First received: June 1, 2009
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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 Intervention
Healthy
Obesity
Drug: ghrelin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Ghrelin on Sympathetic Nervous System and Stress Reactivity

Resource links provided by NLM:


Further study details as provided by Baker IDI Heart and Diabetes Institute:

Primary Outcome Measures:
  • Sympathetic nervous activity [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ghrelin
    0.1 microgram/kg/min, intravenous for 60 minutes
    Other Name: Ghrelin (human) acetate
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912587

Locations
Australia, Victoria
Alfred & Baker Medical Unit
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
  More Information

No publications provided

Responsible Party: Dr Markus Schlaich, Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT00912587     History of Changes
Other Study ID Numbers: 2009/119, 11/09
Study First Received: June 1, 2009
Last Updated: December 19, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014