Cystic Fibrosis
Conditions
Brief summary
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.
Interventions
DRUGSaxagliptin
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.
Sponsors
Ram Weiss
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * No diabetes based on screening OGTT * No C/I for use of the medications * Normal kidney function * Willing and able to participate
Exclusion criteria
* Use of anti-hyperglycemic medications * Acute illness or infection at enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glucose tolerance after treatment with Saxagliptin | The outcome will be measured at 2 timepoints. at baseline and 6 weeks after Saxagliptin treatment | 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. |
Countries
Israel
Contacts
Primary ContactRam Weiss, Professor
Outcome results
None listed