Ghrelin Decreases Insulin Sensitivity

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Ghrelin and saline (as placebo)

• Registration Number: NCT00512525
• Lead Sponsor: University of Aarhus

Brief Summary

Ghrelin administration increases appetite and, in rodents, induces weight gain. The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.

Detailed Description

The current study is initiated in order to assess the impact of acute ghrelin administration on insulin resistance measured by a hyperinsulinemic euglycemic clamp. Second, as free fatty acid is the predominant substrate during fasting, we aim to asses the effects of ghrelin on local and systemic lipolysis.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• healthy men, age >= 18 yr age < 50 yr, body mass index < 27.5 kg/m2above or equal to 18 yr

Exclusion Criteria

• any disease, use of prescribed medication, age < 18 yr or >= 50 yr

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Ghrelin and saline (as placebo)	-

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	End of clamp period

Secondary Outcome Measures

Name	Time	Method
Effects on lipolysis	End of basal and end og clamp period