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| Sponsored by: |
Papworth Hospital |
|---|---|
| Information provided by: | Papworth Hospital |
| ClinicalTrials.gov Identifier: | NCT00763477 |
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: | Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Bio-equivalence Study |
| Official Title: | The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| saline injections: Placebo Comparator |
Biological: ghrelin
subcutaneous injection
|
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:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Papworth Hospital NHS Foundation Trust ( Dr. Alistair Grant ) |
| Study ID Numbers: | P01276 |
| Study First Received: | September 30, 2008 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00763477 |
| Health Authority: | United Kingdom: National Health Service |
|
Cystic fibrosis Weight Appetite Ghrelin Cystic fibrosis with low BMI |
|
Body Weight Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
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Pathologic Processes |
