A Phase 2 interventional study of Acipimox and Placebo in Eating Disorder and Bulimia Nervosa, sponsored by Charles University, Czech Republic. Enrolling by invitation. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Charles University, Czech Republic · Phase 2, Interventional, and Treatment
This study evaluates the addition of Acipimox or placebo to exercise on growth hormone release and ghrelin secretion in bulimic patients and in healthy women. Two groups of participants will receive Acipimox together with exercise versus identical placebo with exercise.
Acipimox and exercise each increase growth hormone release, but they do so by different mechanisms.
Acipimox is an anti-lipolytic drug and increases growth hormone release by decreasing free fatty acids levels and that Acipimox may exert to a negative feedback of growth hormone on ghrelin.
Physical exercise is a potent physiological stimulus for growth hormone release. As ghrelin has a stimulatory effect on growth hormone secretion, growth hormone may inhibit circulating ghrelin levels via a feedback loop. Growth hormone stimulates lipolysis and resultant free fatty acids may suppress ghrelin secretion.
173 studies on the registry are indexed under Bulimia Nervosa; 39 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 121 interventional studies indexed under Bulimia Nervosa.
Browse Bulimia Nervosa studies →Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.
Compared within Bulimia Nervosa, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Feeding and Eating Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Other Names: Olbetam
Drug: Acipimox
Other Names: Placebo (for Olbetam)
Drug: Placebo
Acipimox
Also known as: 5-methylpyrazine-2-carboxylic acid 4-oxide
Placebo Other Names: Placebo (for Olbetam)
Also known as: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule
Changes in plasma growth hormone levels
Plasma growth hormone (mIU/L) levels will be measured by a commercial RIA kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Time frame: baseline and over a total 2 weeks
Changes in extracellular adipose tissue glycerol levels
Extracellular adipose tissue glycerol (umol/L) levels will be measured using microdialysis technique and analyzed with a radiometric kit in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks.
Time frame: baseline and over a total 2 weeks
Changes in body mass index (BMI)
Weight in kilograms and height in meters will be measured in the morning and after exercise alone or together with Acipimox administration over a total of 2 weeks. Weight and height will be combined to report BMI in kg/m2.
Time frame: baseline and over a total 2 weeks
No study locations are listed for this record.
Plan to share: No
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Studies of the drug tested here: Acipimox
Charles University, Czech Republic →