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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056367
First Posted: January 26, 2010
Last Update Posted: October 12, 2011
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 (Responsible Party):
Trine Koustrup Soender, Svendborg Hospital
  Purpose

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
Resistant Hypertension NIDDM

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Resistant Hypertension in Patients With Type-II-Diabetes Mellitus: Prevalence, Characterization and Treatment

Further study details as provided by Trine Koustrup Soender, Svendborg Hospital:

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

Secondary Outcome Measures:
  • Myocardial contractility [ Time Frame: One year ]
  • Pulse wave analysis [ Time Frame: One year ]

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

Enrollment: 180
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-compliance, s-creatinin above 200, AFli
  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): NCT01056367


Locations
Denmark
Department of Medical Research, Svendborg Hospital
Svendborg, Denmark, 5700
Sponsors and Collaborators
Svendborg Hospital
Investigators
Principal Investigator: Trine K Sønder, Cand.med. Department of Medical Research, Svendborg Hospital
  More Information

Responsible Party: Trine Koustrup Soender, Medical Doctor, Svendborg Hospital
ClinicalTrials.gov Identifier: NCT01056367     History of Changes
Other Study ID Numbers: RESIST
First Submitted: January 25, 2010
First Posted: January 26, 2010
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:
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases


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