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Enrolling by Invitation

NCT Number: NCT03338387

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

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.

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Key information

Conditions

Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acipimox

Drug

Acipimox

Other names: 5-methylpyrazine-2-carboxylic acid 4-oxide

Placebo

Drug

Placebo Other Names: Placebo (for Olbetam)

Other names: Cellulose pills manufactured to mimic Acipimox 250Mg Capsule

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2026
First posted
Nov 9, 2017
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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