The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

Insulin Resistance Clinical Trial

Official title:

The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209416
• Other study ID #: M-2010-0157
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: October 27, 2017
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypopituitarism
• Insulin Resistance
• Metabolism

Intervention

Drug:
• Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
• Ghrelin
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day

Other:
• Placebo
placebo tablets or saline infusion

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of ghrelin during basal and hyperinsulinemic conditions	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
Primary	Effects of ghrelin during basal and hyperinsulinemic conditions	Effects of ghrelin on heart rate variability	5 hours investigation day
Primary	Effects of ghrelin during basal and hyperinsulinemic conditions	Effects of ghrelin on thirst, fluid intake, urine production and natriuresis	5 hours investigation day

External Links

•   Original publication on the results from the study