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

Cardiovascular Diseases Clinical Trial

— CARDIPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049737
• Other study ID #: CARDIPP
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: March 7, 2018
• Start date: May 2005
• Est. completion date: December 2012

Study information

• Verified date: March 2018
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

• Not able to understand Swedish

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Sweden	Department of Medical and Health Sciences, Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Dahlén EM, Länne T, Engvall J, Lindström T, Grodzinsky E, Nystrom FH, Ostgren CJ. Carotid intima-media thickness and apolipoprotein B/apolipoprotein A-I ratio in middle-aged patients with Type 2 diabetes. Diabet Med. 2009 Apr;26(4):384-90. doi: 10.1111/j. — View Citation

Wijkman M, Länne T, Engvall J, Lindström T, Ostgren CJ, Nystrom FH. Masked nocturnal hypertension--a novel marker of risk in type 2 diabetes. Diabetologia. 2009 Jul;52(7):1258-64. doi: 10.1007/s00125-009-1369-9. Epub 2009 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 years after baseline investigation
Secondary	Cardiovascular morbidity and mortality		8-12 years after baseline investigation