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The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis

18 Years
80 Years
Open (Enrolling)
Cystic Fibrosis

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Trial Information

The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis

The purpose of this study is to investigate the role of a naturally occuring hormone called
ghrelin on appetite, energy expenditure and immune function in patients with cystic

Theoretical framework:

Despite advances in the molecular understanding of the disease, life−expectancy in Cystic
Fibrosis (CF) remains severely limited. Reduced body−weight is associated with increased
inflammatory lung damage and is a major predictor of mortality in CF patients. Malnutrition
is highly prevalent in the CF population and results from both poor food intake and
excessive energy expenditure. A therapy which improves nutrition may therefore have a
significant effect on the prognosis of this disease. Ghrelin is the only physiological
circulating factor that is known to increase food intake. Administration of acylated ghrelin
to humans increases both hunger and food intake and has been found to increase appetite in
chronic disease states associated with anorexia and weight loss (such as cancer and chronic
renal disease). From multiple animal and in vitro human studies, ghrelin also appears to
have anti−inflammatory properties which would potentially benefit CF patients in whom a
chronic inflammatory state promotes lung destruction, malnutrition and increases mortality.
Ghrelin replacement may therefore improve nutrition and decrease the inflammatory burden in
CF patients, leading to an improvement in life−expectancy. If ghrelin is identified as
having an important pathophysiological role in CF it may lead to a future study of its
efficacy as a therapeutic agent.

Design Methodology: The study has three sections:

1. a cross sectional study of the levels of blood metabolic signals in participants with
cystic fibrosis and healthy controls.

2. a laboratory study of the effect of ghrelin on immune cells extracted from the blood of
participants with cystic fibrosis and healthy controls

3. a cross−over interventional study of repeated ghrelin administration in malnourished
cystic fibrosis patients

Inclusion Criteria:

- Cystic fibrosis

Exclusion Criteria:

- Needle phobia

- Pulmonary infection requiring intravenous antibiotics in the past 2 weeks-

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Outcome Measure:


Outcome Time Frame:

4 weeks

Safety Issue:



United Kingdom: National Health Service

Study ID:




Start Date:

April 2010

Completion Date:

April 2011

Related Keywords:

  • Cystic Fibrosis
  • Cystic fibrosis
  • Weight
  • Appetite
  • Ghrelin
  • Cystic fibrosis with low BMI
  • Cystic Fibrosis
  • Fibrosis