Development of Diabetes in Adults With Cystic Fibrosis (CF)

NCT ID: NCT03644199

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-30
• Study Completion Date: 2017-08-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OGTT test

Comparison of responses to a OGTT between CF subjects and health control subjects

Group Type: OTHER

Oral Glucose Tolerance Test (OGTT) assessment arm

Intervention Type: OTHER

Hormonal and motility responses to a standard OGTT evaluation arm

Mixed meal

Comparison of responses to a mixed meal through the day between CF subjects and health control subjects

Group Type: OTHER

Mixed meal test evaluation test arm

Intervention Type: OTHER

Evaluate the hormonal and motility responses to a standard mixed meal test through the day

Interventions

Oral Glucose Tolerance Test (OGTT) assessment arm

Hormonal and motility responses to a standard OGTT evaluation arm

Intervention Type: OTHER

Mixed meal test evaluation test arm

Evaluate the hormonal and motility responses to a standard mixed meal test through the day

Intervention Type: OTHER

Eligibility Criteria

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dilip Nazareth, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart & Chest Hospital

Locations

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Countries

United Kingdom

Other Identifiers

11-NW-0552

Identifier Type: -

Identifier Source: org_study_id