Cystic Fibrosis Related Diabetes

NCT ID: NCT02148978

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Saxagliptin administration

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.

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ram Weiss

OTHER

Sponsor Role: lead

Responsible Party

Ram Weiss

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Limor Marko, MSc

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Eitan Kerem, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Har Hazofim

Karen Hershkop, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Locations

Hadassah Har Hazofim

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ram Weiss, Professor

Role: CONTACT

ramw@ekmd.huji.ac.il

Facility Contacts

Ram Weiss, MD PhD

Role: primary

ramw@ekmd.huji.ac.il

Other Identifiers

0016-14-HMO

Identifier Type: -

Identifier Source: org_study_id