The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

Not Applicable

Completed

• Conditions: Metabolism; Insulin Resistance; Hypopituitarism
• Interventions: Drug: Acipimox; Drug: Ghrelin; Other: Placebo

• Registration Number: NCT01209416
• Lead Sponsor: University of Aarhus

Brief Summary

This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as signal proteins in fat and muscle biopsies.

Detailed Description

Ghrelin is a relatively 'new' hormone that is produced in the stomach and to a lesser extend in the hypothalamus of the brain. The actions of ghrelin are diverse and includes stimulation of the appetite center of the brain and the release of growth hormone. We have for the first time shown that ghrelin also stimulates the metabolism of fatty acids and induces insulin resistance in skeletal muscle. These effects have we confirmed in growth hormone deficient subjects on a stabile substitution treatment with growth hormone and hydrocortisone. With these subjects we can investigate the effects of ghrelin that are independent of growth hormone. The present study is a continuation of these findings, as we wish to investigate whether the insulin resistance effect of ghrelin is dependent of the concomitant metabolism of fatty acids. This is possible by administration of the niacin acid antagonist Acipimox, that blocks the fatty acid metabolism reversibly. We have applied this experimental principle in other settings with success.

Knowledge of the effects of ghrelin in general can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.

Study Timeline

• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Study Start: 2012-06
• Primary Completion: 2014-10
• Study Completion: 2015-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

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

Inclusion Criteria

• males with hypopituitarism in regard to growth hormone and ACTH in stabile treatment regime
• age 18-65
• BMI 20-35

Exclusion Criteria

• abuse of alcohol
• malign disease
• medication other than that expected for hypopituitarism
• known disease other than hypopituitarism
• participation in isotope investigations the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ghrelin / placebo	Placebo	Ghrelin infusion and placebo tablets
Placebo / placebo	Placebo	saline infusion and placebo tablets
Placebo / Acipimox	Placebo	saline infusion and tablet Acipimox
Placebo / Acipimox	Acipimox	saline infusion and tablet Acipimox
Ghrelin / placebo	Ghrelin	Ghrelin infusion and placebo tablets
Ghrelin / Acipimox	Acipimox	Ghrelin infusion and tablet acipimox
Ghrelin / Acipimox	Ghrelin	Ghrelin infusion and tablet acipimox

Primary Outcome Measures

Name	Time	Method
Effects of ghrelin during basal and hyperinsulinemic conditions	5 hours investigation day	Effects of ghrelin on thirst, fluid intake, urine production and natriuresis

Trial Locations

Locations (1)

University Hospital of Aarhus; 🇩🇰 Aarhus, Denmark