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Ghrelin in Cystic Fibrosis (ghrelin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763477
Recruitment Status : Unknown
Verified July 2010 by Papworth Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2008
Last Update Posted : July 27, 2010
Information provided by:
Papworth Hospital

Brief Summary:

Background to ghrelin Ghrelin is a naturally occurring hormone found in the blood which stimulates appetite. In healthy individuals, levels of ghrelin are high before a meal and falls afterwards. Previous studies have shown that giving ghrelin (by injection) to thin patients with renal failure and cancer increases their food intake. Furthermore, addition of ghrelin may also reduce inflammation within the body. Cystic Fibrosis (CF) is a genetic disease which frequently results in recurrent lung infections (leading to progressive inflammatory lung damage) and low body weight. Low body weight in CF is associated with increased lung infections, rapidly worsening lung function and a shortened life expectancy.

The researchers postulate that administration of extra ghrelin to CF patients with low body weight may increase food intake and reduce lung inflammation. If successful, this study might identify ghrelin as a potential therapy for CF patients to improve nutrition, decrease lung inflammation and thereby improve survival.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Biological: ghrelin Not Applicable

Detailed Description:

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 fibrosis.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis
Study Start Date : April 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Placebo Comparator: saline injections Biological: ghrelin
subcutaneous injection

Primary Outcome Measures :
  1. Appetite [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. weight [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cystic fibrosis
  • BMI </=19 kg/m2

Exclusion Criteria:

  • Needle phobia
  • Pulmonary infection requiring intravenous antibiotics in the past 2 weeks-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763477

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United Kingdom
Papworth Hospital NHs Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Andres R Floto, BM BSc, PhD    01480 830541   
Contact: Jane D Elliott, MPhil    01480 364495      
Principal Investigator: Andres Floto, MB BChir, PhD, FRCP         
Sub-Investigator: Katie J Wynne, MB BChir, PhD, FRCP         
Sponsors and Collaborators
Papworth Hospital
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Responsible Party: Dr. Alistair Grant, Papworth Hospital NHS Foundation Trust Identifier: NCT00763477    
Other Study ID Numbers: P01276
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Keywords provided by Papworth Hospital:
Cystic fibrosis
Cystic fibrosis with low BMI
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases