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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OGTT test | Other | Comparison of responses to a OGTT between CF subjects and health control subjects |
|
| Mixed meal | Other | Comparison of responses to a mixed meal through the day between CF subjects and health control subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) assessment arm | Other | Hormonal and motility responses to a standard OGTT evaluation arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose levels | Glucose sensitivity test | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin responses | Insulin resistance test | 4 hours |
| GLP1 and GIP responses | GLP1 and GIP tests | 4 hours |
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In order to participate in the study, the CF group must meet all the following inclusion criteria
Male or female with a confirmed diagnosis of cystic fibrosis defined by
Aged 18 - 50 years
Out-patients from the regional adult unit in Liverpool
Currently not known to be diabetic or on insulin
Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions
Hemoglobin value >10g/dl
The inclusion criteria for the normal population group is as follows:
In order to participate subjects must not meet any of the following exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dilip Nazareth, MD | Liverpool Heart & Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | L14 3PE | United Kingdom |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Mixed meal test evaluation test arm | Other | Evaluate the hormonal and motility responses to a standard mixed meal test through the day |
|
| Evaluation of gastric emptying | Gastric flow measurement | 8 hours |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |