Preview complete
The prescreener preview is complete. You may now close the preview.
Emergence and Progression of Abnormal Glucose Tolerance in Cystic Fibrosis (Aim 1) (CF Longitudinal)
Recruiting
6 years - 50 years
All
Phase
N/A
Brief description of study
The purpose of this research study is to test how high blood sugar develops and worsens over time in some people with cystic fibrosis.
If you agree to take part, your participation can last for up to 7 years.
As a participant in this research, all participants will:
- Complete overnight fasting
- Complete Mixed Meal Tolerance Tests (MMTT) to test your body’s response to food. This procedure will be completed up to four times over the course of 5 years.
- Complete DXA scans, which measure the amount of fat and lean (non-fat) tissue in the body. This procedure will be completed up to four times over the course of 5 years.
- Complete questionnaires related to physical activity and diet.
- Have research blood and urine tests.
For participants who have not had OGTTs done clinically in the past 6 months:
- Complete Oral Glucose Tolerance Tests (OGTT). The OGTT tests your body’s response to sugar. This procedure will be completed up to four times.
Detailed description of study
You will be compensated for your time. For each visit:
- Screening visit with 2-hour oral glucose tolerance test ($100)
- 4-Hour Mixed Meal Tolerance Test ($250)
- DXA scan ($50)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cystic Fibrosis
-
Age: 6 years - 50 years
-
Gender: All
Inclusion Criteria
Male and female subjects age ≥6 and ≤50 years on date of first phenotyping visit.
Subjects able to provide written informed consent, and, as applicable child assent and/or parental/guardian permission.
Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.
Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.
OGTT consistent with NGT, EGI, or IGT within the previous 6 months.
Exclusion Criteria
Established diagnosis of non-CF diabetes (e.g. type 1 diabetes) or CFRD.
New diagnosis of CFRD based on a 2-hour OGTT glucose ≥200 mg/dL at baseline; individuals who develop CFRD during study participation are of particular interest and will not be excluded
Prior lung or liver transplant.
For GPA: Severe CF liver disease, as defined by portal hypertension.
Fundoplication-related dumping syndrome.
History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to study procedures.
Hemoglobin <10g/dL, most recent within 180 days of study procedures or at screening
For GPA: Abnormal renal function, most recent within 180 days of study procedures or at screening; defined as creatinine > 2x upper limit of normal (ULN) or potassium > 5.5mEq/L on non-hemolyzed specimen.
Inability to perform study specific procedures.
Parents/guardians or subjects who, in study team opinion, may be non-compliant with study procedures.
For female subjects, a positive urine pregnancy test. This will be performed prior to DXA scan, at which point a positive test will result in withdrawal from the study.
Updated on
17 Jan 2025.
Study ID: 834160
Pre-Screener
