The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

Sponsors

Lead Sponsor: University of Aarhus

Source 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.

Overall Status Completed
Start Date June 2012
Completion Date October 2015
Primary Completion Date October 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Effects of ghrelin during basal and hyperinsulinemic conditions 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions 5 hours investigation day
Enrollment 8
Condition
Intervention

Intervention Type: Drug

Intervention Name: Acipimox

Description: Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Other Name: Tablet Olbetam 250 mg

Intervention Type: Drug

Intervention Name: Ghrelin

Description: Ghrelin infusion 4.2 ng/kg/min throughout the investigation day

Intervention Type: Other

Intervention Name: Placebo

Description: placebo tablets or saline infusion

Eligibility

Criteria:

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jens Otto L Jørgensen, Professor Principal Investigator University Hospital of Aarhus
Location
Facility: University Hospital of Aarhus
Location Countries

Denmark

Verification Date

May 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Ghrelin / Acipimox

Type: Active Comparator

Description: Ghrelin infusion and tablet acipimox

Label: Ghrelin / placebo

Type: Active Comparator

Description: Ghrelin infusion and placebo tablets

Label: Placebo / Acipimox

Type: Active Comparator

Description: saline infusion and tablet Acipimox

Label: Placebo / placebo

Type: Placebo Comparator

Description: saline infusion and placebo tablets

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov