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Cystic Fibrosis Related Diabetes

Primary Purpose

Cystic Fibrosis

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Saxagliptin

About this trial

This is an interventional supportive care trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Har HazofimRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saxagliptin administration

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02148978

First Posted

May 15, 2014

Last Updated

May 23, 2014

Sponsor

Ram Weiss

1. Study Identification

Unique Protocol Identification Number

NCT02148978

Brief Title

Cystic Fibrosis Related Diabetes

Official Title

DPP-IV Inhibition in Patients With Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ram Weiss

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Saxagliptin administration

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Saxagliptin

Intervention Description

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.

Primary Outcome Measure Information:

Title

glucose tolerance after treatment with Saxagliptin

Description

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.

Time Frame

The outcome will be measured at 2 timepoints. at baseline and 6 weeks after Saxagliptin treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ram Weiss, Professor

ramw@ekmd.huji.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Limor Marko, MSc

Organizational Affiliation

Hebrew University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eitan Kerem, MD

Organizational Affiliation

Hadassah Har Hazofim

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Karen Hershkop, PhD

Organizational Affiliation

Hebrew University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Har Hazofim

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ram Weiss, MD PhD

ramw@ekmd.huji.ac.il

12. IPD Sharing Statement

Learn more about this trial

Cystic Fibrosis Related Diabetes

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