Development of Diabetes in Adults With Cystic Fibrosis (CF)

Not Applicable

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Other: Mixed meal test evaluation test arm; Other: Oral Glucose Tolerance Test (OGTT) assessment arm

• Registration Number: NCT03644199
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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 Timeline

• Study Start: 2011-03-30
• Primary Completion: 2013-07-30
• Study First Submitted: 2016-05-10
• Study Completion: 2017-08-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-21
• Last Update Submitted: 2018-08-21
• Study First Posted: 2018-08-23
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mixed meal	Mixed meal test evaluation test arm	Comparison of responses to a mixed meal through the day between CF subjects and health control subjects
OGTT test	Oral Glucose Tolerance Test (OGTT) assessment arm	Comparison of responses to a OGTT between CF subjects and health control subjects

Primary Outcome Measures

Name	Time	Method
Glucose levels	4 hours	Glucose sensitivity test

Secondary Outcome Measures

Name	Time	Method
Evaluation of gastric emptying	8 hours	Gastric flow measurement
GLP1 and GIP responses	4 hours	GLP1 and GIP tests
Insulin responses	4 hours	Insulin resistance test

Trial Locations

Locations (1)

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom