Ghrelin in Cystic Fibrosis

NCT00763477 | Unknown DMC

• 1 other identifier: P01276
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Weight; Appetite; Ghrelin; Cystic fibrosis with low BMI

Outcome Measures

Primary Outcomes (1)

• Appetite

  4 weeks

Secondary Outcomes (1)

• weight

  4 weeks

Study Arms (1)

saline injections

PLACEBO COMPARATOR

Biological: ghrelin

Interventions

ghrelin BIOLOGICAL

subcutaneous injection

saline injections

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cystic fibrosis
• BMI \</=19 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital NHs Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Body Weight

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 27, 2010

Record last verified: 2010-07

Locations

GB (1)