Cystic Fibrosis Related Diabetes

Not Applicable

• Conditions: Cystic Fibrosis
• Interventions: Drug: Saxagliptin

• Registration Number: NCT02148978
• Lead Sponsor: Ram Weiss

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-23
• Last Update Submitted: 2014-05-23
• Study First Posted: 2014-05-29
• Last Update Posted: 2014-05-29
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saxagliptin administration	Saxagliptin	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hadassah Har Hazofim; 🇮🇱 Jerusalem, Israel