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

September 21, 2011 updated by: Peter Rossing, Steno Diabetes Center Copenhagen

Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

type 1 diabetic patients (600 patients) non-diabetic controls (50)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
type 1 diabetes
non-diabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Investigators

  • Principal Investigator: Peter Rossing, MD, DmSc, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (Estimate)

July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFIL-H-B-2009-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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