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

Phase 2

• Conditions: Bulimia Nervosa; Eating Disorder
• Interventions: Drug: Placebo; Drug: Acipimox

• Registration Number: NCT03338387
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2003-05-06
• Primary Completion: 2007-12-16
• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Other Names: Placebo (for Olbetam)
Acipimox	Acipimox	Other Names: Olbetam

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.