Overview

This trial is active, not recruiting.

Conditions metabolism, insulin resistance, hypopituitarism
Treatments acipimox, ghrelin, placebo
Sponsor University of Aarhus
Start date June 2012
End date October 2014
Trial size 8 participants
Trial identifier NCT01209416, M-2010-0157

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Active Comparator)
Ghrelin infusion and tablet acipimox
acipimox Tablet Olbetam 250 mg
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
ghrelin Ghrelin
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
(Active Comparator)
Ghrelin infusion and placebo tablets
ghrelin Ghrelin
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
placebo Placebo tablets
placebo tablets or saline infusion
(Active Comparator)
saline infusion and tablet Acipimox
acipimox Tablet Olbetam 250 mg
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
placebo Placebo tablets
placebo tablets or saline infusion
(Placebo Comparator)
saline infusion and placebo tablets
placebo Placebo tablets
placebo tablets or saline infusion

Primary Outcomes

Measure
Effects of ghrelin during basal and hyperinsulinemic conditions
time frame: 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
time frame: 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
time frame: 5 hours investigation day

Eligibility Criteria

Male participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin
Principal investigator Jens Otto L Jørgensen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.