Clinical trial

Acipimox Administration Together With Short-Term Exercise Exerts A Co-Feedback of Growth Hormone, Pancreatic Polypeptide, Peptide YY and Leptin on Ghrelin in Young Bulimic Czech Women: A Randomized Study

Name
AZV Grant Agency
Description
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.
Trial arms
Trial start
2003-05-06
Estimated PCD
2007-12-16
Trial end
2023-12-20
Phase
Early phase I
Treatment
Acipimox
Acipimox
Arms:
Acipimox
Other names:
5-methylpyrazine-2-carboxylic acid 4-oxide
Placebo
Placebo Other Names: Placebo (for Olbetam)
Arms:
Placebo
Other names:
Cellulose pills manufactured to mimic Acipimox 250Mg Capsule
Size
24
Primary endpoint
Changes in plasma growth hormone levels
baseline and over a total 2 weeks
Eligibility criteria
Inclusion Criteria: * Patients with a diagnosis of bulimia nervosa * Body mass index (BMI) between 18 and 23 kg/m2 Exclusion Criteria: * History of heart disease * History of bleeding disorders * Subjects with diabetes type 1 or 2, hypo- or hyperthyroidism * Subjects with hepatogastroenteric disease * Pregnant, trying to become pregnant or breast feeding * Patients with other psychiatric diseases
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2023-09-05

1 organization

1 product

1 drug

2 indications

Organization
Charles University
Product
Acipimox
Indication
Eating Disorder
Indication
Bulimia nervosa