NCT02776098Completed
Muscle Accrual and Function in Cystic Fibrosis-Impact of Glucose Intolerance
Source: ClinicalTrials.gov · Last updated 7 Mar 2024
Brief summary (registry, in English)
This study will investigate the link between glucose abnormalities and elements critical to muscle function including mass, composition and energy metabolism. the primary goal of the study is to determine whether Cystic Fibrosis (CF) disease is associated with muscle dysfunction, especially in the presence of glucose intolerance. This is a longitudinal cohort study of 3 main groups: CF subjects without Cystic Fibrosis-related diabetes (CFRD), healthy matched controls and CF subjects with newly diagnosed CFRD started on insulin therapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 54 (actual)
- First submitted
- 16 May 2016
- Start date
- May 2016
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Cystic fibrosis
- NCT number
- NCT02776098
What you commit to
- Study type: Observational
- Participants enrolled: 54
- From May 2016 to the primary completion date, 4 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplantation
- Established diagnosis of CFRD and treatment with insulin or hypoglycemic agent
- Organ transplantation
Other illness
- Chronic systemic glucocorticoid use e.g. for allergic bronchopulmonary aspergillosis
- Pre-existing neurological or neuromuscular disease
- All study visits for CF subjects will be scheduled during periods of baseline health. Visits will not be performed within 4 weeks of an acute respiratory illness or pulmonary exacerbation.
- Pre-existing neurological or neuromuscular disease
- Chronic systemic glucocorticoid use e.g. for allergic bronchopulmonary aspergillosis
- Pre-existing neurological or neuromuscular disease
Other
- Forced Expiratory Volume (FFEV) 1%-predicted \< 40%
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Pregnancy or breastfeeding (if female)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Pregnancy or breastfeeding (if female)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Pregnancy or breastfeeding (if female)
Who the study is looking for
- Males or females age 16 to 22 years.
- Confirmed diagnosis of CF per CF Foundation guidelines
- Parental/guardian permission (informed consent) and if appropriate, child assent.
- Age-, sex-, ethnicity-, and BMI-matched at time of enrollment to CF subjects without CFRD
- Parental/guardian permission (informed consent) and if appropriate, child assent.
- Males or females age 12 years or above.
- Confirmed diagnosis of CF per CF Foundation guidelines.
- New diagnosis of CFRD based on a) a clinically indicated Oral glucose tolerance test (OGTT) b) hyperglycemia (PG\>200 mg/dL) persisting \>48 hours and/or c) elevated HbA1C and within 4 weeks of starting insulin therapy.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Age in the registry: 12 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.