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.
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
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.
- Conditions
- Cystic Fibrosis Related Diabetes
- 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.
- First posted22 Sep 2005 (estimated)
- Study startApr 2001
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Vikings Children Fund, Moran, Antoinette, M.D.
- Responsible party
- Sponsor
- Investigators
- Antoinette Moran, MD, Principal investigator, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Complications of Cystic Fibrosis Related Diabetes
- ClinicalTrials.gov ID
- NCT00222508
- Acronym / sponsor ID
- 0012M75862
- Conditions
- Cystic Fibrosis Related Diabetes
- Keywords
- Cystic Fibrosis, Diabetes, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Vikings Children Fund, Moran, Antoinette, M.D.
- Study start
- Apr 2001
- Study completion
- Jul 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CFRD Patients
Key inclusion criteria (1 listed)
- CFRD patients with and without fasting hyperglycemia
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette Moran, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
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.