Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia
|ClinicalTrials.gov Identifier: NCT03338387|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2017
Last Update Posted : July 24, 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, 2020|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338387
|Principal Investigator:||Kvido Smitka, M.D., Ph.D.||Charles University|