The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

October 27, 2017 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • University Hospital of Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ghrelin / Acipimox
Ghrelin infusion and tablet acipimox
Drug: Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Other Names:
  • Tablet Olbetam 250 mg
Drug: Ghrelin
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
Active Comparator: Ghrelin / placebo
Ghrelin infusion and placebo tablets
Drug: Ghrelin
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
Other: Placebo
placebo tablets or saline infusion
Other Names:
  • Placebo tablets
  • Saline infusion
Active Comparator: Placebo / Acipimox
saline infusion and tablet Acipimox
Drug: Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Other Names:
  • Tablet Olbetam 250 mg
Other: Placebo
placebo tablets or saline infusion
Other Names:
  • Placebo tablets
  • Saline infusion
Placebo Comparator: Placebo / placebo
saline infusion and placebo tablets
Other: Placebo
placebo tablets or saline infusion
Other Names:
  • Placebo tablets
  • Saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of ghrelin during basal and hyperinsulinemic conditions
Time Frame: 5 hours investigation day
Growth hormone deficient patient investigated with ghrelin infusion and pharmacological antilipolysis (Acipimox) in a randomized cross-over study with 4 study days. During each visit signal proteins in muscle and fat biopsies are investigated with PCR, wester blot and activity assays for ghrelin, growth hormone and insulin. Further is glucose metabolism investigated in basal conditions and during hyperinsulinemic euglycemic clamp.
5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
Time Frame: 5 hours investigation day
Effects of ghrelin on heart rate variability
5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
Time Frame: 5 hours investigation day
Effects of ghrelin on thirst, fluid intake, urine production and natriuresis
5 hours investigation day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jens Otto L Jørgensen, Professor, University Hospital of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2010-0157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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