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Clinical Trials/NCT03644199
NCT03644199
Withdrawn
Not Applicable

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

ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Locations
1
Primary Endpoint
Glucose levels
Status
Withdrawn
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2011
End Date
August 30, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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)

Study Sites (1)

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