Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
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|ClinicalTrials.gov Identifier: NCT03338387|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorder Bulimia Nervosa||Drug: Acipimox Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Start Date :||May 6, 2003|
|Actual Primary Completion Date :||December 16, 2007|
|Estimated Study Completion Date :||February 20, 2019|
Other Names: Olbetam
Other Name: 5-methylpyrazine-2-carboxylic acid 4-oxide
Placebo Comparator: Placebo
Placebo (for Olbetam)
Placebo Other Names: Placebo (for Olbetam)
Other Name: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule
- Changes in plasma growth hormone levels [ Time Frame: 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.
- Changes in extracellular adipose tissue glycerol levels [ Time Frame: 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.
- Changes in body mass index (BMI) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338387
|Principal Investigator:||Kvido Smitka, M.D., Ph.D.||Charles University|