Cystic Fibrosis Related Diabetes

Cystic Fibrosis Clinical Trial

Official title:

DPP-IV Inhibition in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02148978
• Other study ID #: 0016-14-HMO
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2014
• Last updated: May 23, 2014
• Start date: March 2014

Study information

• Verified date: May 2014
• Source: Hadassah Medical Organization
• Contact: Ram Weiss, Professor
• Email: ramw[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Saxagliptin
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.

Locations

Country	Name	City	State
Israel	Hadassah Har Hazofim	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Ram Weiss

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No