NCT00912587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

June 1, 2009

Last Update Submit

September 13, 2023

Conditions

HealthyObesity

Outcome Measures

Primary Outcomes (1)

  • Sympathetic nervous activity

    60 min

Secondary Outcomes (1)

  • blood pressure

    60 min

Interventions

ghrelinDRUG

0.1 microgram/kg/min, intravenous for 60 minutes

Also known as: Ghrelin (human) acetate

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred & Baker Medical Unit

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Obesity

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

AU(1)