Cystic Fibrosis-related Diabetes Clinical Trial
Official title:
Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis
Verified date | July 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women = 18 with CF and one of the following: - Normal OGTT - Elevated OGTT - Known CFRD Exclusion Criteria: - Men and women without CF |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Trustees of Dartmouth College |
United States,
Colomba J, Netedu SR, Lehoux-Dubois C, Coriati A, Boudreau V, Tremblay F, Cusi K, Rabasa-Lhoret R, Leey JA. Hepatic enzyme ALT as a marker of glucose abnormality in men with cystic fibrosis. PLoS One. 2019 Jul 18;14(7):e0219855. doi: 10.1371/journal.pone. — View Citation
Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul;24(7):908-922. doi: 10.1038/s41591-018-0104-9. Epub 2018 Jul 2. — View Citation
Hui JM, Sud A, Farrell GC, Bandara P, Byth K, Kench JG, McCaughan GW, George J. Insulin resistance is associated with chronic hepatitis C virus infection and fibrosis progression [corrected]. Gastroenterology. 2003 Dec;125(6):1695-704. doi: 10.1053/j.gast — View Citation
Kayani K, Mohammed R, Mohiaddin H. Cystic Fibrosis-Related Diabetes. Front Endocrinol (Lausanne). 2018 Feb 20;9:20. doi: 10.3389/fendo.2018.00020. eCollection 2018. — View Citation
Toledano MB, Mukherjee SK, Howell J, Westaby D, Khan SA, Bilton D, Simmonds NJ. The emerging burden of liver disease in cystic fibrosis patients: A UK nationwide study. PLoS One. 2019 Apr 4;14(4):e0212779. doi: 10.1371/journal.pone.0212779. eCollection 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess Phenotype of CFLD | Assess phenotype of CFLD via a Fibroscan performed after a >3 hour fast | Visit 1, Day 1 | |
Primary | Assess Value of Complete Blood Count of CFLD | Assess phenotype of CFLD via a complete blood count (CBC) | Visit 1, Day 1 | |
Primary | Assess Hepatic Function of CFLD | Assess phenotype of CFLD via a hepatic function test | Visit 1, Day 1 | |
Primary | Assess Oral Glucose of CFLD | Assess phenotype of CFLD via an oral glucose tolerance test | Visit 1, Day 1 | |
Primary | Assess CFLD via abdominal imaging | Assess phenotype of CFLD via abdominal imaging (CT abdomen, Ultrasound, or MRI). If the subject has had a CT of the abdomen, Ultrasound or MRI of the abdomen as part of their standard care, the data will be collected. These procedures will not be performed as part of this study. | Visit 1, Day 1 |
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