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Clinical Trials/NCT03644199
NCT03644199WithdrawnNot Applicable

Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis

Liverpool Heart and Chest Hospital NHS Foundation Trust2 sites in 1 countryStarted: March 30, 2011Last updated:
Conditions
Interventions

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Withdrawn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:

  1. To determine whether pancreatic fatigue contributes to this delayed insulin release and peak that is seen in patients with cystic fibrosis.
  2. 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?
  3. To determine if gastric emptying has a role to play in the development of CFRD?
  4. To study the hormone release response to a glucose challenge and the patterns of change through the day.
  5. 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

Other

Comparison of responses to a OGTT between CF subjects and health control subjects

Intervention: Oral Glucose Tolerance Test (OGTT) assessment arm (Other)

Mixed meal

Other

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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