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

This study has been completed.
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Identifier:
First received: July 27, 2010
Last updated: September 21, 2011
Last verified: September 2011
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.

Type 1 Diabetes Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Peter Rossing, Steno Diabetes Center:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 650
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
type 1 diabetes


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)

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
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Please refer to this study by its identifier: NCT01171248

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Rossing, Senior Physician, DMSc, Steno Diabetes Center Identifier: NCT01171248     History of Changes
Other Study ID Numbers: PROFIL-H-B-2009-056
Study First Received: July 27, 2010
Last Updated: September 21, 2011

Keywords provided by Peter Rossing, Steno Diabetes Center:
nocturnal blood pressure dip
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 processed this record on September 21, 2017