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

C

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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