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The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

NCT ID: NCT01209416

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Metabolism Insulin Resistance Hypopituitarism

Keywords

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ghrelin metabolism type 2 diabetes insulin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ghrelin / Acipimox

Ghrelin infusion and tablet acipimox

Group Type ACTIVE_COMPARATOR

Acipimox

Intervention Type DRUG

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

Ghrelin

Intervention Type DRUG

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

Ghrelin / placebo

Ghrelin infusion and placebo tablets

Group Type ACTIVE_COMPARATOR

Ghrelin

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

placebo tablets or saline infusion

Placebo / Acipimox

saline infusion and tablet Acipimox

Group Type ACTIVE_COMPARATOR

Acipimox

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

placebo tablets or saline infusion

Placebo / placebo

saline infusion and placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo tablets or saline infusion

Interventions

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Acipimox

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

Intervention Type DRUG

Ghrelin

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

Intervention Type DRUG

Placebo

placebo tablets or saline infusion

Intervention Type OTHER

Other Intervention Names

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Tablet Olbetam 250 mg Placebo tablets Saline infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Otto L Jørgensen, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Aarhus

Locations

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University Hospital of Aarhus

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Jepsen SL, Vestergaard ET, Larraufie P, Gribble FM, Reimann F, Jorgensen JOL, Holst JJ, Kuhre RE. Ghrelin Does Not Directly Stimulate Secretion of Glucagon-like Peptide-1. J Clin Endocrinol Metab. 2020 Jan 1;105(1):266-75. doi: 10.1210/clinem/dgz046.

Reference Type DERIVED
PMID: 31608930 (View on PubMed)

Vestergaard ET, Cichosz SL, Moller N, Jorgensen JOL, Fleischer J. Short-term acipimox treatment is associated with decreased cardiac parasympathetic modulation. Br J Clin Pharmacol. 2017 Dec;83(12):2671-2677. doi: 10.1111/bcp.13384. Epub 2017 Aug 24.

Reference Type DERIVED
PMID: 28736944 (View on PubMed)

Related Links

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https://www.nature.com/articles/srep42706

Original publication on the results from the study

Other Identifiers

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M-2010-0157

Identifier Type: -

Identifier Source: org_study_id