AzTrials
AzTrials

Cystic Fibrosis Related DiabetesNCT00222508

The Microvascular Complications Study

An observational study of Cystic Fibrosis Related Diabetes, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cystic Fibrosis Related Diabetes
How many people
150 participants
Where
1 siteUnited States
Study dates
Apr 2001to Jul 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: CFRD Patients

Who may be able to join

  • CFRD patients with and without fasting hyperglycemia

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Microvascular Complications of Cystic Fibrosis Related Diabetes

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.

Read the 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.

Keywords
Cystic Fibrosis, Diabetes, Complications
Medical subject headings
Cystic Fibrosis, Diabetes Mellitus

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startApr 2001
  3. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00222508
Sponsor's protocol ID
0012M75862
Status last verified
Jul 2012
First submitted
14 Sep 2005
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis Related Diabetes, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in