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Resistant Hypertension in Patients With Type-II-Diabetes Mellitus (RESIST)

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. Identifier: NCT01056367
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Trine Koustrup Soender, Svendborg Hospital

Brief Summary:

The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of patients.

Hypertension is a major risk factor for CVD in patients with type-II-DM and a major contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.

The prevalence of UH and RH has not been examined in a consecutive Danish outpatient population with type-II-DM.

The purpose of this study is to examine the prevalence of resistant hypertension in patients with type-II-diabetes and to examine the characteristics of patients with resistant hypertension as compared to patients with controlled hypertension with regards to arterial stiffness.

Condition or disease
Resistant Hypertension NIDDM

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Study Type : Observational
Actual Enrollment : 180 participants
Time Perspective: Prospective
Official Title: Resistant Hypertension in Patients With Type-II-Diabetes Mellitus: Prevalence, Characterization and Treatment
Study Start Date : June 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Myocardial contractility [ Time Frame: One year ]
  2. Pulse wave analysis [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Only serum and plasma samples are used and saved for later analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from diabetic outpatient clinic

Inclusion Criteria:

  • 18-80 years, informed consent, hypertension, type-II-diabetes mellitus

Exclusion Criteria:

  • Non-compliance, s-creatinin above 200, AFli

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 identifier (NCT number): NCT01056367

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Department of Medical Research, Svendborg Hospital
Svendborg, Denmark, 5700
Sponsors and Collaborators
Svendborg Hospital
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Principal Investigator: Trine K Sønder, Department of Medical Research, Svendborg Hospital
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Responsible Party: Trine Koustrup Soender, Medical Doctor, Svendborg Hospital Identifier: NCT01056367    
Other Study ID Numbers: RESIST
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Keywords provided by Trine Koustrup Soender, Svendborg Hospital:
Resistant hypertension
Type-II-Diabetes Mellitus
Arterial stiffness
Ventricular function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases