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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.
Sponsor:
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01171248
First received: July 27, 2010
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Ambulatory blood pressure (AMBP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
type 1 diabetes
non-diabetics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 27, 2010
Last Updated: September 21, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013