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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trine Koustrup Soender, Svendborg Hospital
ClinicalTrials.gov Identifier:
NCT01056367
First received: January 25, 2010
Last updated: October 9, 2011
Last verified: October 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Svendborg Hospital:

Primary Outcome Measures:
  • Pulse wave velocity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial contractility [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Pulse wave analysis [ Time Frame: One year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Trine Koustrup Soender, Medical Doctor, Svendborg Hospital
ClinicalTrials.gov Identifier: NCT01056367     History of Changes
Other Study ID Numbers: RESIST
Study First Received: January 25, 2010
Last Updated: October 9, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Svendborg Hospital:
Resistant hypertension
Type-II-Diabetes Mellitus
Arterial stiffness
Ventricular function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013