NCT03644199

Development of Diabetes in Adults With Cystic Fibrosis (CF)

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
OTHER	Oral Glucose Tolerance Test (OGTT) assessment arm	Hormonal and motility responses to a standard OGTT evaluation arm
OTHER	Mixed meal test evaluation test arm	Evaluate the hormonal and motility responses to a standard mixed meal test through the day

Timeline

• Start date: 2011-03-30
• Primary completion: 2013-07-30
• Completion: 2017-08-30
• First posted: 2018-08-23
• Last updated: 2018-08-23

Locations

1 site across 1 country: United Kingdom