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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014