Ghrelin in Cystic Fibrosis (ghrelin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Papworth Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Papworth Hospital
ClinicalTrials.gov Identifier:
NCT00763477
First received: September 30, 2008
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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 Intervention
Cystic Fibrosis
Biological: ghrelin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Papworth Hospital:

Primary Outcome Measures:
  • Appetite [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline injections Biological: ghrelin
subcutaneous injection

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Needle phobia
  • Pulmonary infection requiring intravenous antibiotics in the past 2 weeks-
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763477

Locations
United Kingdom
Papworth Hospital NHs Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Andres R Floto, BM BSc, PhD    01480 830541    andres.floto@papworth.nhs.uk   
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
  More Information

No publications provided

Responsible Party: Dr. Alistair Grant, Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00763477     History of Changes
Other Study ID Numbers: P01276
Study First Received: September 30, 2008
Last Updated: July 26, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by Papworth Hospital:
Cystic fibrosis
Weight
Appetite
Ghrelin
Cystic fibrosis with low BMI

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014