We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Orthostatic Hypotension and Diabetes Mellitus (ODET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807976
First Posted: December 15, 2008
Last Update Posted: October 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Research Foundation, The Netherlands
  Purpose

Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects.

Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects.

Study design: Cross-sectional observational study.

Study population: Elderly type 2 diabetic subjects (70 years and older).


Condition
Orthostatic Hypotension Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • Prevalence of orthostatic hypotension [ Time Frame: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study) ]

Secondary Outcome Measures:
  • Adverse events, Score risk profile questionnaire, Heart rate, Gender, Body mass index, Medication, Smoking, History of cardiovascular disease, Family history of cardiovascular disease, Duration of diabetes mellitus, Glycosylated haemoglobin, Insulin use [ Time Frame: 1-12 months (the outcome measures are assessed only once during the running time of the study) ]

Estimated Enrollment: 500
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group
Type 2 diabetic patients aged 70 years and older.
Control group
Patients aged 70 years and older, with no history of type 2 diabetes mellitus.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic patients aged 70 years and older
Criteria

Inclusion Criteria:

  • diabetes mellitus
  • age (70 years and older)

Exclusion Criteria:

  • Known autonomic dysfunction
  • Neurodegenerative diseases
  • Current malignancy
  • Living in a nursing-home
  • Irregular pulse
  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): NCT00807976


Locations
Netherlands
Diabetes centre, Isala Clinics
Zwolle, Netherlands, 8000 GM
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Principal Investigator: Kornelis JJ van Hateren, MD Diabetes centre, Isala Clinics
  More Information

Responsible Party: Kornelis J.J. van Hateren, Medical research foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT00807976     History of Changes
Other Study ID Numbers: ODET1
First Submitted: December 11, 2008
First Posted: December 15, 2008
Last Update Posted: October 8, 2010
Last Verified: October 2010

Keywords provided by Medical Research Foundation, The Netherlands:
Diabetes mellitus
Elderly
Orthostatic hypotension

Additional relevant MeSH terms:
Diabetes Mellitus
Hypotension
Diabetes Mellitus, Type 2
Hypotension, Orthostatic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases