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Orthostatic Hypotension and Diabetes Mellitus (ODET)

This study has been completed.
Sponsor:
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00807976
First received: December 11, 2008
Last updated: October 7, 2010
Last verified: October 2010
History of Changes
  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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kornelis J.J. van Hateren, Medical research foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT00807976     History of Changes
Other Study ID Numbers: ODET1
Study First Received: December 11, 2008
Last Updated: October 7, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypotension
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

ClinicalTrials.gov processed this record on May 22, 2013