Cystic Fibrosis Related Diabetes

NCT02148978 | Unknown

• 1 other identifier: 0016-14-HMO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: Saxagliptin

Interventions

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.

Saxagliptin administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of anti-hyperglycemic medications
• Acute illness or infection at enrollment

Sponsors & Collaborators

• Ram Weiss: lead

Study Sites (1)

Hadassah Har Hazofim

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Limor Marko, MSc

  Hebrew University

  PRINCIPAL INVESTIGATOR

• Eitan Kerem, MD

  Hadassah Har Hazofim

  PRINCIPAL INVESTIGATOR

• Karen Hershkop, PhD

  Hebrew University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ram Weiss, Professor

CONTACT

ramw@ekmd.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 29, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

IL (1)