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Trial record 16 of 393 for:    PYY

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
Sponsor:
Information provided by (Responsible Party):
Kvido Smitka, Charles University, Czech Republic

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.

Condition or disease Intervention/treatment Phase
Eating Disorder Bulimia Nervosa Drug: Acipimox Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acipimox
Other Names: Olbetam
Drug: Acipimox
Acipimox
Other Name: 5-methylpyrazine-2-carboxylic acid 4-oxide

Placebo Comparator: Placebo

Other Names:

Placebo (for Olbetam)

Drug: Placebo
Placebo Other Names: Placebo (for Olbetam)
Other Name: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Kvido Smitka, M.D., Ph.D. Charles University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kvido Smitka, M.D., Ph.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03338387     History of Changes
Other Study ID Numbers: AZV Grant Agency
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kvido Smitka, Charles University, Czech Republic:
neuropeptides
microdialysis

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Bulimia
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Hormones
Pancreatic Polypeptide
Acipimox
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Gastrointestinal Agents