Development of Diabetes in Adults With Cystic Fibrosis (CF) (CF-DIABETES)
Primary Purpose
Cystic Fibrosis
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oral Glucose Tolerance Test (OGTT) assessment arm
Mixed meal test evaluation test arm
Sponsored by
About this trial
This is an interventional other trial for Cystic Fibrosis focused on measuring Gastric emptying, Cystic Fibrosis related diabetes, Incretins
Eligibility Criteria
In order to participate in the study, the CF group must meet all the following inclusion criteria
Male or female with a confirmed diagnosis of cystic fibrosis defined by
- Clinical features consistent with a diagnosis of CF AND
- Sweat chloride ≥60mmol/L by pilocarpine ionotophoresis; OR
- Genotypic confirmation of CFTR mutation
- Aged 18 - 50 years
- Out-patients from the regional adult unit in Liverpool
- Currently not known to be diabetic or on insulin
- Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
- Hemoglobin value >10g/dl
The inclusion criteria for the normal population group is as follows:
- Male or female with NO confirmed diagnosis of cystic fibrosis
- Aged 18 - 50 years
- Currently not known to be diabetic or on insulin
- Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
- Hemoglobin value >10g/dl
In order to participate subjects must not meet any of the following exclusion criteria
- Patients with known diabetes or on glucose lowering medications (insulin, oral agents)
- On-going acute illness
- Those on long-term oral steroids
- Pregnant women
- Those on immunosuppressive treatment
- History of, or planned organ transplant
- Clinically significant abnormal findings on haematology or clinical chemistry
- Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator.
- Current malignant disease
- Any serious or active medical or psychiatric illness, which in eth opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
Sites / Locations
- Liverpool Heart and Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
OGTT test
Mixed meal
Arm Description
Comparison of responses to a OGTT between CF subjects and health control subjects
Comparison of responses to a mixed meal through the day between CF subjects and health control subjects
Outcomes
Primary Outcome Measures
Glucose levels
Glucose sensitivity test
Secondary Outcome Measures
Insulin responses
Insulin resistance test
GLP1 and GIP responses
GLP1 and GIP tests
Evaluation of gastric emptying
Gastric flow measurement
Full Information
NCT ID
NCT03644199
First Posted
May 10, 2016
Last Updated
August 21, 2018
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03644199
Brief Title
Development of Diabetes in Adults With Cystic Fibrosis (CF)
Acronym
CF-DIABETES
Official Title
Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of resources
Study Start Date
March 30, 2011 (Anticipated)
Primary Completion Date
July 30, 2013 (Anticipated)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
4. Oversight
5. Study Description
Brief Summary
This is a crossover study to determine the possible factors that might be related to the development of diabetes in CF and examines the relationship between pancreatic fatigue if any, and the development of diabetes. In addition hormones affecting the release of insulin and stomach motility will be studied to determine if there is a variation in response to solid and liquid meals and if this variation increases as fatigue progresses.
Detailed Description
The main purpose of this study is to look at possible additional factors that might be related to the development of Cystic Fibrosis Related Diabetes (CFRD), that in itself is a unique entity and to identify an appropriate test to diagnose CFRD. There is well demonstrated evidence of delayed insulin release and peak in individuals with CF, the cause of which is not fully explained.
With a view to determine the cause of this phenomenon the aims of this study are:
To determine whether pancreatic fatigue contributes to this delayed insulin release and peak that is seen in patients with cystic fibrosis.
Should a glucose tolerance test be done at a later time in the day, as against first thing in the morning as is the current accepted standard?
To determine if gastric emptying has a role to play in the development of CFRD?
To study the hormone release response to a glucose challenge and the patterns of change through the day.
To study the relationship of these hormones to gastric emptying and the development of diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Gastric emptying, Cystic Fibrosis related diabetes, Incretins
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OGTT test
Arm Type
Other
Arm Description
Comparison of responses to a OGTT between CF subjects and health control subjects
Arm Title
Mixed meal
Arm Type
Other
Arm Description
Comparison of responses to a mixed meal through the day between CF subjects and health control subjects
Intervention Type
Other
Intervention Name(s)
Oral Glucose Tolerance Test (OGTT) assessment arm
Intervention Description
Hormonal and motility responses to a standard OGTT evaluation arm
Intervention Type
Other
Intervention Name(s)
Mixed meal test evaluation test arm
Intervention Description
Evaluate the hormonal and motility responses to a standard mixed meal test through the day
Primary Outcome Measure Information:
Title
Glucose levels
Description
Glucose sensitivity test
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Insulin responses
Description
Insulin resistance test
Time Frame
4 hours
Title
GLP1 and GIP responses
Description
GLP1 and GIP tests
Time Frame
4 hours
Title
Evaluation of gastric emptying
Description
Gastric flow measurement
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
In order to participate in the study, the CF group must meet all the following inclusion criteria
Male or female with a confirmed diagnosis of cystic fibrosis defined by
Clinical features consistent with a diagnosis of CF AND
Sweat chloride ≥60mmol/L by pilocarpine ionotophoresis; OR
Genotypic confirmation of CFTR mutation
Aged 18 - 50 years
Out-patients from the regional adult unit in Liverpool
Currently not known to be diabetic or on insulin
Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
Hemoglobin value >10g/dl
The inclusion criteria for the normal population group is as follows:
Male or female with NO confirmed diagnosis of cystic fibrosis
Aged 18 - 50 years
Currently not known to be diabetic or on insulin
Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
Hemoglobin value >10g/dl
In order to participate subjects must not meet any of the following exclusion criteria
Patients with known diabetes or on glucose lowering medications (insulin, oral agents)
On-going acute illness
Those on long-term oral steroids
Pregnant women
Those on immunosuppressive treatment
History of, or planned organ transplant
Clinically significant abnormal findings on haematology or clinical chemistry
Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator.
Current malignant disease
Any serious or active medical or psychiatric illness, which in eth opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip Nazareth, MD
Organizational Affiliation
Liverpool Heart & Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Development of Diabetes in Adults With Cystic Fibrosis (CF)
We'll reach out to this number within 24 hrs