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Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections and exocrine pancreatic insufficiency. The vast majority of patients with CF will develop pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.
The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, additional mechanisms may be involved. The investigators have recently shown that insulin secretion in patients with CF is significantly altered prior to the development of diabetes. This phenomenon is associated with reduced secretion of gut derived incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether due to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced secretion or due to rapid clearance of such peptides) may be a major underlying driver of altered glucose metabolism in such patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin administration | Experimental | Saxagliptin Administration- The participants in this study will undergo an OGTT (Oral Glucose Tolerance Test) at recruitment and then will start treatment with the DPP IV inhibitor- Saxagliptin. After 6 weeks of treatment the participants will return to perform a second OGTT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | The participants in this study will undergo an OGTT at recruitment and then will start treatment with the DPP IV inhibitor- Saxagliptin at a dose between 2.5- 5mg a day. After 6 weeks of treatment the participants will return to perform a second OGTT. |
| Measure | Description | Time Frame |
|---|---|---|
| glucose tolerance after treatment with Saxagliptin | Bloods taken during the OGTT will be analyzed for Glucose, Insulin, C-peptide and glucagon levels. Gut hormone levels and incretins will also be valued. | The outcome will be measured at 2 timepoints. at baseline and 6 weeks after Saxagliptin treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ram Weiss, Professor | Contact | ramw@ekmd.huji.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Limor Marko, MSc | Hebrew University | Principal Investigator |
| Eitan Kerem, MD | Hadassah Har Hazofim | Principal Investigator |
| Karen Hershkop, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Har Hazofim | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
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| Hebrew University |
| Principal Investigator |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |