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Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes (PROFIL)

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ClinicalTrials.gov Identifier: NCT01171248
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.

Condition or disease
Type 1 Diabetes Hypertension

Study Design

Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients
Study Start Date : September 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
type 1 diabetes
non-diabetics


Outcome Measures

Primary Outcome Measures :
  1. Ambulatory blood pressure (AMBP) [ Time Frame: 2 years ]
    The participants are seen once (cross-sectional) and we measure AMBP in order for us to investigate any association between AMBP and other parameters such as age, duration of diabetes, albuminuria status and other diabetic complications.


Secondary Outcome Measures :
  1. Diabetic late complications [ Time Frame: 2 years ]
    The participants are only seen once and are at this visit, asked in regards to complications, and the electronic patient medical record is rewieved in regards to complications.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
type 1 diabetic patients (600 patients) non-diabetic controls (50)
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • more than 18 years of age

Exclusion Criteria:

  • End Stage Renal Disease (ESRD)
  • dialysis
  • other kidney disease than diabetic nephropathy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171248


Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center
Investigators
Principal Investigator: Peter Rossing, MD, DmSc Steno Diabetes Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Rossing, Senior Physician, DMSc, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01171248     History of Changes
Other Study ID Numbers: PROFIL-H-B-2009-056
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by Peter Rossing, Steno Diabetes Center:
nocturnal blood pressure dip
complications
ambulatory blood pressure

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases