Eating Disorder, Bulimia Nervosa
Conditions
Keywords
neuropeptides, microdialysis
Brief summary
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.
Detailed description
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.
Interventions
DRUGAcipimox
Acipimox
DRUGPlacebo
Placebo Other Names: Placebo (for Olbetam)
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma growth hormone levels | baseline and over a total 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in extracellular adipose tissue glycerol levels | baseline and over a total 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in body mass index (BMI) | baseline and over a total 2 weeks | 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. |
Outcome results
None listed