Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care (CARDIPP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01049737
First received: January 13, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

The purpose of this study is to prospectively explore the impact from the different cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients with type 2 diabetes.


Condition
Diabetes Mellitus Type 2
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Left ventricular mass index by cardiac ultrasonography, Intima media thickness by carotid ultrasonographic investigation and tonometry for measurements of the carotid, femoral and radial pulse pressure wave form and pulse wave velocity [ Time Frame: 4 years after baseline investigation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular morbidity and mortality [ Time Frame: 8-12 years after baseline investigation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples were drawn in the fasting state and analysed for levels of HbA1c, hs-CRP, cytokines, lipid and lipoprotein status etc. RNA is extracted from whole blood and the PPAR-gamma isoform was determined after RT-PCR and analysis of DNA sequence. Several small vials of plasma and serum are stored for later analysis of different hormones, cytokines and antibodies (when the economy of the project allows this, high priority is antibodies against GAD and islet beta-cells and levels of hormones such as resistin, adiponectin, leptin and markers of inflammation in terms of cytokines as IL-1, IL-6, IL-10). Other genetic polymorphisms of importance for risk assessment will also be analysed when the economy allows this.


Enrollment: 761
Study Start Date: May 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

CARDIPP (Cardiovascular Risk factors in Patients with Diabetes - a Prospective study in Primary care) was launched in 2005 with the aim of identifying markers for cardiovascular disease to facilitate earlier and individually adjusted intervention in middle aged patients with type 2 diabetes. The patients in CARDIPP were consecutively recruited from primary health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005 through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the participation in the study was performed as an extended annual follow up. Blood pressure was measured as the average of three seated measurements taken 1 minute apart and standard anthropometric and clinic evaluations were performed including measurement of waist circumference and sagittal abdominal diameter which is a new and promising measurement of abdominal obesity that may serve as a surrogate marker of insulin sensitivity. We also obtained a recording of 24-hour ambulatory blood pressure. The patients filled out a detailed questionnaire for evaluation of life style factors and exercise habits. Pedometer-determined ambulatory activity for three consecutive days in combination with the questionnaires was used for quantification of daily physical activity.

The cardiovascular investigations were performed at the Department of Physiology, Linköping University Hospital and at County Hospital Ryhov, Jönköping, Sweden. The patients were subjected to cardiac ultrasonography for calculation of left ventricular mass and ejection fraction as well as diastolic cardiac function. Measurement of the carotid, femoral and radial pulse pressure wave form is performed by aid of tonometry, with pressure wave analysis and calculation of central blood pressure. Furthermore, pulse wave velocity in both central elastic and muscular peripheral arteries is defined as an index of arterial wall stiffness. The intima-media thickness (IMT) and the lumen diameter (LD) of the carotid arteries were evaluated using a B-mode ultrasound.

CARDIPP-R comprises a re-investigation of the cohort four years after the completion of the baseline examination and will thus start in November 2009 and will be completed by 2012. In CARDIPP-R, all participants from the baseline study will be invited to the re-investigation. The CARDIPP-R study protocol for the cardiac ultrasonography, the carotid ultrasonographic investigations and tonometry for measurements of the carotid, femoral and radial pulse pressure wave form and pulse wave velocity will follow the CARDIPP baseline protocol.

  Eligibility

Ages Eligible for Study:   55 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patients in CARDIPP were consecutively recruited from primary health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005 through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the participation in the study was performed as an extended annual follow up.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

  • Not able to understand Swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049737

Locations
Sweden
Department of Medical and Health Sciences, Linköping University
Linköping, Sweden, SE-581 83
Sponsors and Collaborators
Linkoeping University
Investigators
Study Director: Carl J Östgren, PhD Linköping University
Principal Investigator: Fredrik H Nyström, Professor Linköping University
Principal Investigator: Toste Länne, Professor Linköping University
Principal Investigator: Jan Engvall, PhD Linköping University
Principal Investigator: Torbjörn Lindström, PhD Linköping University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carl Johan Östgren/Principal Investigator, Department of Medical and Health Sciences
ClinicalTrials.gov Identifier: NCT01049737     History of Changes
Other Study ID Numbers: CARDIPP
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014