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

Charles University, Czech Republic

Status and phase: Invitation-only; Phase 2

Conditions: Eating Disorder; Bulimia Nervosa

Treatments: Drug: Placebo; Drug: Acipimox

Study type: Interventional

Funder types: Other

Identifiers

NCT03338387

AZV Grant Agency

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Acipimox

Experimental group

Description:

Other Names: Olbetam

Treatment:

Drug: Acipimox

Placebo

Placebo Comparator group

Description:

Other Names: Placebo (for Olbetam)

Treatment:

Drug: Placebo

Sponsor of this trial

Lead Sponsor

Charles University, Czech Republic