Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222508
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2005-09-14
Brief Title:
The Microvascular Complications Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Microvascular Complications of Cystic Fibrosis Related Diabetes
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our general aim is to determine the prevalence of diabetic microvascular complications in CFRD patients with and without fasting hyperglycemia and to explore whether the presence of these complications is related to diabetes or CF factors This cross-sectional study will provide pilot data for a longitudinal study of diabetes complications in CF
Detailed Description:
Microvascular complications of diabetes such as eye kidney and nerve disease are common in individuals with type 1 and type 2 diabetes and are a source of significant morbidity and mortality Microvascular diabetes complications have been anecdotally reported in cystic fibrosis related diabetes CFRD but their prevalence is unknown 40 of adult CF patients have CFRD which shares features of both type 1 and type 2 diabetes but is a distinct clinical entity 1 Many clinicians are reluctant to add the burden of aggressive diabetes management to the already complex medical regimen of these patients It is sometimes stated that they will not live long enough to develop complications of diabetes However longevity in CF has dramatically increased and many patients now live into their thirties forties and fifties As they live longer it becomes increasingly likely that at least some will develop diabetes complications A better understanding of this negative outcome would help resolve the question of whether aggressive screening and management of diabetes is necessary in CF
As in other forms of diabetes duration of diabetes and the magnitude of chronic hyperglycemia are probably important determinants of microvascular complications in CFRD This information is not usually known at the time of presentation of CFRD because of the insidious onset of the disease Theoretically CF pulmonary disease including chronic hypoxia and venous congestion related to pulmonary hypertension may additionally aggravate microvascular changes However the metabolic differences between CFRD and type 1 and type 2 diabetes may also serve to protect CF patients from some diabetes complications At the time diabetes complications develop patients with type 1 and type 2 diabetes tend to have concomitant obesity hypertension insulin resistance hyperlipidemia and atherosclerotic cardiovascular disease These factors which are generally absent in CF may contribute to the pathophysiology of microvascular complications in other forms of diabetes
The University of Minnesota CF Center is in the unique position of having a well-characterized diabetes population since diabetes screening was instituted several years ago as part of routine annual CF studies In our population of 450 CF patients 113 have been diagnosed with diabetes and the remainder are known to have either normal or impaired glucose tolerance In addition to our CFRD experience the University of Minnesota has a strong background of experience in large population-based screening and intervention trials concerning diabetes complications Not only were we a participating center in the NIH-sponsored multi-center Diabetes Control and Complications Trial DCCT 2 and the current DCCT follow-up Epidemiology of Diabetes Interventions and Complications trial EDIC but our laboratory was central reference laboratory for the DCCT and EDIC Thus our physicians nurses biostatisticians GCRC staff and laboratory staff are all quite knowledgeable and experienced in the methods to be used in the present application
As in other forms of diabetes duration of diabetes and the magnitude of chronic hyperglycemia are probably important determinants of microvascular complications in CFRD This information is not usually known at the time of presentation of CFRD because of the insidious onset of the disease Theoretically CF pulmonary disease including chronic hypoxia and venous congestion related to pulmonary hypertension may additionally aggravate microvascular changes However the metabolic differences between CFRD and type 1 and type 2 diabetes may also serve to protect CF patients from some diabetes complications At the time diabetes complications develop patients with type 1 and type 2 diabetes tend to have concomitant obesity hypertension insulin resistance hyperlipidemia and atherosclerotic cardiovascular disease These factors which are generally absent in CF may contribute to the pathophysiology of microvascular complications in other forms of diabetes
The University of Minnesota CF Center is in the unique position of having a well-characterized diabetes population since diabetes screening was instituted several years ago as part of routine annual CF studies In our population of 450 CF patients 113 have been diagnosed with diabetes and the remainder are known to have either normal or impaired glucose tolerance In addition to our CFRD experience the University of Minnesota has a strong background of experience in large population-based screening and intervention trials concerning diabetes complications Not only were we a participating center in the NIH-sponsored multi-center Diabetes Control and Complications Trial DCCT 2 and the current DCCT follow-up Epidemiology of Diabetes Interventions and Complications trial EDIC but our laboratory was central reference laboratory for the DCCT and EDIC Thus our physicians nurses biostatisticians GCRC staff and laboratory staff are all quite knowledgeable and experienced in the methods to be used in the present application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None