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

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ClinicalTrials.gov Identifier: NCT01049737
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Johan Ostgren, Linkoeping University

Tracking Information
First Submitted Date January 13, 2010
First Posted Date January 14, 2010
Last Update Posted Date March 8, 2018
Study Start Date May 2005
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 13, 2010)
Cardiovascular morbidity and mortality [ Time Frame: 8-12 years after baseline investigation ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care
Official Title Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Diabetes Mellitus Type 2
  • Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2010)
761
Original Actual Enrollment Same as current
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

  • Not able to understand Swedish
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01049737
Other Study ID Numbers CARDIPP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carl Johan Ostgren, Linkoeping University
Study Sponsor Linkoeping University
Collaborators Not Provided
Investigators
Study Director: Carl J Östgren, PhD Linkoeping University
Principal Investigator: Fredrik H Nyström, Professor Linkoeping University
Principal Investigator: Toste Länne, Professor Linkoeping University
Principal Investigator: Jan Engvall, PhD Linkoeping University
Principal Investigator: Torbjörn Lindström, PhD Linkoeping University
PRS Account Linkoeping University
Verification Date March 2018