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The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01209416
First received: September 24, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Metabolism
Insulin Resistance
Hypopituitarism
Drug: Acipimox
Drug: Ghrelin
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effects of ghrelin during basal and hyperinsulinemic conditions [ Time Frame: 5 hours investigation day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tablet Olbetam 250 mg
Drug: Ghrelin
Ghrelin infusion 16,9 ng/kg/min throughout the investigation day
Other Name: Ghrelin
Active Comparator: Ghrelin / placebo
Ghrelin infusion and placebo tablets
Drug: Ghrelin
Ghrelin infusion 16,9 ng/kg/min throughout the investigation day
Other Name: Ghrelin
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209416

Contacts
Contact: Esben T Vestergaard, Post doc etv@dadlnet.dk
Contact: Jens Otto L Jørgensen, Professor +45 89492025 jolj@svf.au.dk

Locations
Denmark
University Hospital of Aarhus Recruiting
Aarhus, Denmark, 8000
Contact: Esben T Vestergaard       etv@dadlnet.dk   
Contact: Jens Otto L Jørgensen    +4589492025    jolj@svf.au.dk   
Principal Investigator: Jens Otto L Jørgensen, Professor         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens Otto L Jørgensen, Professor University Hospital of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01209416     History of Changes
Other Study ID Numbers: M-2010-0157
Study First Received: September 24, 2010
Last Updated: August 8, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
ghrelin
metabolism
type 2 diabetes
insulin resistance

Additional relevant MeSH terms:
Pituitary Diseases
Hypopituitarism
Insulin Resistance
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Hypothalamic Diseases
Metabolic Diseases
Nervous System Diseases
Acipimox
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014