Development of Diabetes in Adults With Cystic Fibrosis (CF) (CF-DIABETES)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Oral Glucose Tolerance Test (OGTT) assessment arm; Other: Mixed meal test evaluation test arm

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

In order to participate in the study, the CF group must meet all the following inclusion criteria

1. Male or female with a confirmed diagnosis of cystic fibrosis defined by

   1. Clinical features consistent with a diagnosis of CF AND
   2. Sweat chloride ≥60mmol/L by pilocarpine ionotophoresis; OR
   3. Genotypic confirmation of CFTR mutation
2. Aged 18 - 50 years
3. Out-patients from the regional adult unit in Liverpool
4. Currently not known to be diabetic or on insulin
5. Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
6. Hemoglobin value >10g/dl

The inclusion criteria for the normal population group is as follows:

1. Male or female with NO confirmed diagnosis of cystic fibrosis
2. Aged 18 - 50 years
3. Currently not known to be diabetic or on insulin
4. Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
5. Hemoglobin value >10g/dl

In order to participate subjects must not meet any of the following exclusion criteria

1. Patients with known diabetes or on glucose lowering medications (insulin, oral agents)
2. On-going acute illness
3. Those on long-term oral steroids
4. Pregnant women
5. Those on immunosuppressive treatment
6. History of, or planned organ transplant
7. Clinically significant abnormal findings on haematology or clinical chemistry
8. Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator.
9. Current malignant disease
10. Any serious or active medical or psychiatric illness, which in eth opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OGTT test; Comparison of responses to a OGTT between CF subjects and health control subjects	Other: Oral Glucose Tolerance Test (OGTT) assessment arm; Hormonal and motility responses to a standard OGTT evaluation arm
Other: Mixed meal; Comparison of responses to a mixed meal through the day between CF subjects and health control subjects	Other: Mixed meal test evaluation test arm; Evaluate the hormonal and motility responses to a standard mixed meal test through the day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	Glucose sensitivity test	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin responses	Insulin resistance test	4 hours
GLP1 and GIP responses	GLP1 and GIP tests	4 hours
Evaluation of gastric emptying	Gastric flow measurement	8 hours

Collaborators and Investigators

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Dilip Nazareth, MD, Liverpool Heart & Chest Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2011
• Primary Completion (Anticipated): July 30, 2013
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Gastric emptying; Incretins; Cystic Fibrosis related diabetes
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 11-NW-0552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED