Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Glucose levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
OGTT test
Comparison of responses to a OGTT between CF subjects and health control subjects
Intervention: Oral Glucose Tolerance Test (OGTT) assessment arm (Other)
Mixed meal
Comparison of responses to a mixed meal through the day between CF subjects and health control subjects
Intervention: Mixed meal test evaluation test arm (Other)
Outcomes
Primary Outcomes
Glucose levels
Time Frame: 4 hours
Glucose sensitivity test
Secondary Outcomes
- Evaluation of gastric emptying(8 hours)
- Insulin responses(4 hours)
- GLP1 and GIP responses(4 hours)