Growth Hormone for Cystic Fibrosis-Related Wasting
This phase 1 study aims to evaluate the safety and effects of growth hormone therapy on weight changes in adults with cystic fibrosis-related wasting.
Nutropin AQ
Cystic Fibrosis+5
+ Digestive System Diseases
+ Infant, Newborn, Diseases
Treatment Study
Summary
Study start date: November 1, 2008
Actual date on which the first participant was enrolled.This study focuses on using Growth Hormone (GH) therapy to address wasting, which is severe weight loss, in adults who have Cystic Fibrosis (CF). Wasting can greatly impact the quality of life and overall health of individuals with CF. By exploring how GH therapy affects weight, quality of life, and diabetes management in these patients, the study aims to improve treatment strategies for CF-related complications. This research is important because it could lead to better ways to help CF patients maintain a healthier weight, improve their quality of life, and manage diabetes, which are significant challenges in their care. Participants in this study will receive Growth Hormone therapy and will have their progress monitored in several ways. Their weight changes will be tracked to see if there is any improvement from the baseline. Additionally, body composition will be assessed using bioelectrical impedance analysis to measure changes in fat-free mass. Quality of life will be evaluated using CF-specific questionnaires, and adherence to the therapy will be monitored through patient reports. The study will also examine the therapy's impact on diabetes, looking at insulin sensitivity and glycemic control. Changes in lung function, muscle strength, and certain serum markers will also be evaluated to understand the broader effects of the therapy. The study is in its early phase, which means it is primarily focused on understanding the treatment's effects and safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location