An interventional study of Acipimox and Placebo in Hypopituitarism, Insulin Resistance and Endocrine System Diseases, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These protein anabolic effects require sufficient nutritional supply. During fasting and caloric restriction GH predominantly promotes fat metabolism.
GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose uptake in skeletal muscle has been most extensively studied. Substrate competition between elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the fat metabolizing effects of GH.
The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.
In order to investigate this, eight adult hypopituitary patients with documented GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively, and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.
Knowledge of the effects of growth hormone and fat metabolism 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.
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.
Browse Hypopituitarism 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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Drug: Acipimox Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day Other Name: Tablet Olbetam 250 mg Continue GH substitution as usually.
Drug: Acipimox · Drug: GH substitution
Drug: Acipimox Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day Other Name: Tablet Olbetam 250 mg Pause GH substitution to days prior to the study day.
Drug: Acipimox · Other: GH pause
Drug: Placebo tablets Continue GH substitution as usually.
Drug: Placebo · Drug: GH substitution
Drug: Placebo tablets Pause GH substitution to days prior to the study day.
Drug: Placebo · Other: GH pause
Acipimox is administered 4 times previous to and during the investigation day. Acipimox is used to suppress the lipolytic effect of GH.
Also known as: Olbetam
Placebo is administered 4 times previous to and during the investigation day.
GH substitution as usually
GH substitution pause two days prior to the experimental day
Lipolytic activity measured as area under the curve (AUC) for FFA (free fatty acid) before and during clamp-conditions.
Time frame: 1 year
GH signaling proteins and gene targets in adipose and skeletal muscle tissues measured by western blotting and qPCR
Time frame: 1,5 years
Insulin sensitivity as measured by M value and GIR (glucose infusion rate)
Time frame: 6 months
Substrate metabolism as measured by indirect calorimetry, tritiated glucose and circulating hormones and metabolites
Time frame: 1 year
PDH (pyruvate dehydrogenase) activity in skeletal muscle measured by an PDH activity assay
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acipimox