An interventional study of Acipimox and Ghrelin in Metabolism, Insulin Resistance and Hypopituitarism, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-30.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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.
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.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's planned enrollment of 8 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ghrelin infusion and tablet acipimox
Drug: Acipimox · Drug: Ghrelin
Ghrelin infusion and placebo tablets
Drug: Ghrelin · Other: Placebo
saline infusion and tablet Acipimox
Drug: Acipimox · Other: Placebo
saline infusion and placebo tablets
Other: Placebo
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Also known as: Tablet Olbetam 250 mg
Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
placebo tablets or saline infusion
Also known as: Placebo tablets, Saline infusion
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.
Time frame: 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
Effects of ghrelin on heart rate variability
Time frame: 5 hours investigation day
Effects of ghrelin during basal and hyperinsulinemic conditions
Effects of ghrelin on thirst, fluid intake, urine production and natriuresis
Time frame: 5 hours investigation day
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acipimox · Ghrelin