Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Eating Disorder, Bulimia Nervosa

Intervention / Treatment
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* Drug: Acipimox
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acipimox<br>Other Names: Olbetam | Drug: Acipimox<br>* Acipimox<br>* Other names: 5-methylpyrazine-2-carboxylic acid 4-oxide;|
| Placebo Comparator: Placebo<br>Other Names: Placebo (for Olbetam) | Drug: Placebo<br>* Placebo Other Names: Placebo (for Olbetam)<br>* Other names: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and over a total 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and over a total 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropeptides, microdialysis