Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care (CARDIPP)
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| ClinicalTrials.gov Identifier: NCT01049737 |
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Recruitment Status :
Completed
First Posted : January 14, 2010
Last Update Posted : March 8, 2018
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| Condition or disease |
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| Diabetes Mellitus Type 2 Cardiovascular Diseases |
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 |
| Actual Enrollment : | 761 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
- 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 ]
- Cardiovascular morbidity and mortality [ Time Frame: 8-12 years after baseline investigation ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 55 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes
Exclusion Criteria:
- Not able to understand Swedish
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049737
| Sweden | |
| Department of Medical and Health Sciences, Linköping University | |
| Linköping, Sweden, SE-581 83 | |
| 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carl Johan Ostgren, Professor, MD PhD, Linkoeping University |
| ClinicalTrials.gov Identifier: | NCT01049737 History of Changes |
| Other Study ID Numbers: |
CARDIPP |
| First Posted: | January 14, 2010 Key Record Dates |
| Last Update Posted: | March 8, 2018 |
| Last Verified: | March 2018 |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Cardiovascular Diseases |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |