Development of Diabetes in Adults With Cystic Fibrosis (CF)

Cystic Fibrosis Clinical Trial

— CF-DIABETES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03644199
• Other study ID #: 11-NW-0552
• Status: Withdrawn
• Phase: N/A
• Start date: March 30, 2011
• Est. completion date: August 30, 2017

Study information

• Verified date: August 2018
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2017
• Est. primary completion date: July 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Oral Glucose Tolerance Test (OGTT) assessment arm
Hormonal and motility responses to a standard OGTT evaluation arm
• Mixed meal test evaluation test arm
Evaluate the hormonal and motility responses to a standard mixed meal test through the day

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels	Glucose sensitivity test	4 hours
Secondary	Insulin responses	Insulin resistance test	4 hours
Secondary	GLP1 and GIP responses	GLP1 and GIP tests	4 hours
Secondary	Evaluation of gastric emptying	Gastric flow measurement	8 hours