The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin
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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 |
- 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:
|
|
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 Comparator: Placebo / placebo
saline infusion and placebo tablets
|
Other: Placebo
placebo tablets or saline infusion
Other Names:
|
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 |
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| Contact: Esben T Vestergaard, Post doc | etv@dadlnet.dk | |
| Contact: Jens Otto L Jørgensen, Professor | +45 89492025 | jolj@svf.au.dk |
| 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 | |
| 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:
|
Hypopituitarism Insulin Resistance Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Acipimox Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013