Suspended

Growth Hormone for Cystic Fibrosis-Related Wasting

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Study Aim

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.

What is being tested

Nutropin AQ

Drug
Who is being recruted

Cystic Fibrosis+5

+ Digestive System Diseases

+ Infant, Newborn, Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2008
See protocol details

Summary

Principal SponsorUniversity of Massachusetts, Worcester
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleGrowth Hormone Therapy for Wasting in Cystic Fibrosis
Principal SponsorUniversity of Massachusetts, Worcester
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cystic FibrosisDigestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesRespiratory Tract DiseasesGenetic Diseases, Inborn

Criteria

7 inclusion criteria required to participate
Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Age > 18 years

Cystic fibrosis, diagnosed by either sweat chloride or genetic testing

Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men

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10 exclusion criteria prevent from participating
Pregnancy (positive pregnancy test) prior enrollment in the study

Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

Participation in another simultaneous medical investigation or trial

Pediatric patients

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Nutropin Aqueous (AQ): Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d

Study 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

Suspended

Umms/Ummhc

Worcester, United StatesOpen Umms/Ummhc in Google Maps
SuspendedOne Study Center