Orthostatic Hypotension and Diabetes Mellitus

NCT00807976 | Completed

• 1 other identifier: ODET1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Orthostatic Hypotension; Diabetes Mellitus Type 2

Keywords

Diabetes mellitus; Elderly; Orthostatic hypotension

Outcome Measures

Primary Outcomes (1)

• Prevalence of orthostatic hypotension

  1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)

Secondary Outcomes (1)

• 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

  1-12 months (the outcome measures are assessed only once during the running time of the study)

Study Arms (2)

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 Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic patients aged 70 years and older

You may qualify if:

• diabetes mellitus
• age (70 years and older)

You may not qualify if:

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

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (1)

Diabetes centre, Isala Clinics

Zwolle, 8000 GM, Netherlands

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kornelis JJ van Hateren, MD

  Diabetes centre, Isala Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 15, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 8, 2010

Record last verified: 2010-10

Locations

NL (1)