Diabetes Mellitus Type 2CARDIPPNCT01049737
Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care
An observational study of Diabetes Mellitus Type 2 and Cardiovascular Diseases, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Cardiovascular Diseases
- How many people
- 761 participants
- Where
- 1 siteSweden
- Study dates
- May 2005to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of type 2 diabetes
Who cannot join
- Not able to understand Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medical and Health Sciences, Linköping University
Linköping, SE-581 83
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2, Cardiovascular Diseases
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years after baseline investigation
Secondary outcomes (1)
Cardiovascular morbidity and mortality
Measured: 8-12 years after baseline investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startMay 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carl Johan Ostgren, Linkoeping University
- Investigators
- Carl J Östgren, PhD, Study director, Linkoeping UniversityFredrik H Nyström, Professor, Principal investigator, Linkoeping UniversityToste Länne, Professor, Principal investigator, Linkoeping UniversityJan Engvall, PhD, Principal investigator, Linkoeping UniversityTorbjörn Lindström, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049737
- Sponsor's protocol ID
- CARDIPP
- Acronym
- CARDIPP
- Status last verified
- Mar 2018
- First submitted
- 13 Jan 2010
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahlen EM, Lanne T, Engvall J, Lindstrom 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.1464-5491.2009.02693.x.
PubMed 19388968Wijkman M, Lanne T, Engvall J, Lindstrom 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.
PubMed 19396423Davidson LT, Chisalita SI, Gauffin E, Engvall J, Ostgren CJ, Nystrom FH. Plasma copeptin independently predicts cardiovascular events but not all-cause mortality in patients with type 2 diabetes: a prospective observational study. Nutr Metab Cardiovasc Dis. 2025 Nov;35(11):104158. doi: 10.1016/j.numecd.2025.104158. Epub 2025 May 19.
PubMed 40617713Vergara M, Ostgren CJ, Nystrom FH, Israelsson H. Sense of vitality is associated with cardiovascular events in type 2 diabetes independently of traditional risk factors and arterial stiffness. Diabet Med. 2023 Feb;40(2):e14938. doi: 10.1111/dme.14938. Epub 2022 Aug 30.
PubMed 36039920Johansson MA, Vavruch C, Ostgren CJ, Nystrom FH. Circulating TNFrII levels predict incidence of ischemic heart disease and total mortality, independently of intima media thickness and pulse wave velocity in male with type 2 diabetes. Heart Vessels. 2021 Oct;36(10):1591-1596. doi: 10.1007/s00380-021-01857-4. Epub 2021 Apr 19.
PubMed 33871700Vavruch C, Nowak C, Feldreich T, Ostgren CJ, Sundstrom J, Soderberg S, Lind L, Nystrom F, Arnlov J. Using proximity extension proteomics assay to discover novel biomarkers associated with circulating leptin levels in patients with type 2 diabetes. Sci Rep. 2020 Aug 4;10(1):13097. doi: 10.1038/s41598-020-69473-2.
PubMed 32753620Chisalita SI, Wijkman M, Davidson LT, Spangeus A, Nystrom F, Ostgren CJ. Toe brachial index predicts major acute cardiovascular events in patients with type 2 diabetes independently of arterial stiffness. Diabetes Res Clin Pract. 2020 Mar;161:108040. doi: 10.1016/j.diabres.2020.108040. Epub 2020 Jan 29.
PubMed 32006647Blomstrand P, Sjoblom P, Nilsson M, Wijkman M, Engvall M, Lanne T, Nystrom FH, Ostgren CJ, Engvall J. Overweight and obesity impair left ventricular systolic function as measured by left ventricular ejection fraction and global longitudinal strain. Cardiovasc Diabetol. 2018 Aug 14;17(1):113. doi: 10.1186/s12933-018-0756-2.
PubMed 30107798Radholm K, Tengblad A, Dahlen E, Lanne T, Engvall J, Nystrom FH, Ostgren CJ. The impact of using sagittal abdominal diameter to predict major cardiovascular events in European patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2017 May;27(5):418-422. doi: 10.1016/j.numecd.2017.02.001. Epub 2017 Feb 16.
PubMed 28390663Wijkman M, Lanne T, Ostgren CJ, Nystrom FH. Aortic pulse wave velocity predicts incident cardiovascular events in patients with type 2 diabetes treated in primary care. J Diabetes Complications. 2016 Sep-Oct;30(7):1223-8. doi: 10.1016/j.jdiacomp.2016.06.008. Epub 2016 Jun 19.
PubMed 27400814Jennersjo P, Guldbrand H, Bjorne S, Lanne T, Fredrikson M, Lindstrom T, Wijkman M, Ostgren CJ, Nystrom FH. A prospective observational study of all-cause mortality in relation to serum 25-OH vitamin D3 and parathyroid hormone levels in patients with type 2 diabetes. Diabetol Metab Syndr. 2015 Jun 12;7:53. doi: 10.1186/s13098-015-0049-9. eCollection 2015.
PubMed 26078787Vavruch C, Lanne T, Fredrikson M, Lindstrom T, Ostgren CJ, Nystrom FH. Serum leptin levels are independently related to the incidence of ischemic heart disease in a prospective study of patients with type 2 diabetes. Cardiovasc Diabetol. 2015 May 22;14:62. doi: 10.1186/s12933-015-0208-1.
PubMed 25994184Dahlen EM, Tengblad A, Lanne T, Clinchy B, Ernerudh J, Nystrom FH, Ostgren CJ. Abdominal obesity and low-grade systemic inflammation as markers of subclinical organ damage in type 2 diabetes. Diabetes Metab. 2014 Feb;40(1):76-81. doi: 10.1016/j.diabet.2013.10.006. Epub 2013 Nov 26.
PubMed 24290615Dahlen EM, Bjarnegard N, Lanne T, Nystrom FH, Ostgren CJ. Sagittal abdominal diameter is a more independent measure compared with waist circumference to predict arterial stiffness in subjects with type 2 diabetes--a prospective observational cohort study. Cardiovasc Diabetol. 2013 Mar 28;12:55. doi: 10.1186/1475-2840-12-55.
PubMed 23536999Wijkman M, Lanne T, Grodzinsky E, Ostgren CJ, Engvall J, Nystrom FH. Ambulatory systolic blood pressure predicts left ventricular mass in type 2 diabetes, independent of central systolic blood pressure. Blood Press Monit. 2012 Aug;17(4):139-44. doi: 10.1097/MBP.0b013e328355fdfb.
PubMed 22735793
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care
- ClinicalTrials.gov ID
- NCT01049737
- Acronym / sponsor ID
- CARDIPP / CARDIPP
- Conditions
- Diabetes Mellitus Type 2, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- May 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of type 2 diabetes
Key exclusion criteria (1 listed)
- Not able to understand Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Cardiovascular morbidity and mortality
Time frame: 8-12 years after baseline investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Results publication: PubMed 19388968Dahlen EM, Lanne T, Engvall J, Lindstrom 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.1464-5491.2009.02693.x.
- Results publication: PubMed 19396423Wijkman M, Lanne T, Engvall J, Lindstrom 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.
- Derived from this study: PubMed 40617713Davidson LT, Chisalita SI, Gauffin E, Engvall J, Ostgren CJ, Nystrom FH. Plasma copeptin independently predicts cardiovascular events but not all-cause mortality in patients with type 2 diabetes: a prospective observational study. Nutr Metab Cardiovasc Dis. 2025 Nov;35(11):104158. doi: 10.1016/j.numecd.2025.104158. Epub 2025 May 19.
- Derived from this study: PubMed 36039920Vergara M, Ostgren CJ, Nystrom FH, Israelsson H. Sense of vitality is associated with cardiovascular events in type 2 diabetes independently of traditional risk factors and arterial stiffness. Diabet Med. 2023 Feb;40(2):e14938. doi: 10.1111/dme.14938. Epub 2022 Aug 30.
- Derived from this study: PubMed 33871700Johansson MA, Vavruch C, Ostgren CJ, Nystrom FH. Circulating TNFrII levels predict incidence of ischemic heart disease and total mortality, independently of intima media thickness and pulse wave velocity in male with type 2 diabetes. Heart Vessels. 2021 Oct;36(10):1591-1596. doi: 10.1007/s00380-021-01857-4. Epub 2021 Apr 19.
- Derived from this study: PubMed 32753620Vavruch C, Nowak C, Feldreich T, Ostgren CJ, Sundstrom J, Soderberg S, Lind L, Nystrom F, Arnlov J. Using proximity extension proteomics assay to discover novel biomarkers associated with circulating leptin levels in patients with type 2 diabetes. Sci Rep. 2020 Aug 4;10(1):13097. doi: 10.1038/s41598-020-69473-2.
- Derived from this study: PubMed 32006647Chisalita SI, Wijkman M, Davidson LT, Spangeus A, Nystrom F, Ostgren CJ. Toe brachial index predicts major acute cardiovascular events in patients with type 2 diabetes independently of arterial stiffness. Diabetes Res Clin Pract. 2020 Mar;161:108040. doi: 10.1016/j.diabres.2020.108040. Epub 2020 Jan 29.
- Derived from this study: PubMed 30107798Blomstrand P, Sjoblom P, Nilsson M, Wijkman M, Engvall M, Lanne T, Nystrom FH, Ostgren CJ, Engvall J. Overweight and obesity impair left ventricular systolic function as measured by left ventricular ejection fraction and global longitudinal strain. Cardiovasc Diabetol. 2018 Aug 14;17(1):113. doi: 10.1186/s12933-018-0756-2.
- Derived from this study: PubMed 28390663Radholm K, Tengblad A, Dahlen E, Lanne T, Engvall J, Nystrom FH, Ostgren CJ. The impact of using sagittal abdominal diameter to predict major cardiovascular events in European patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2017 May;27(5):418-422. doi: 10.1016/j.numecd.2017.02.001. Epub 2017 Feb 16.
- Derived from this study: PubMed 27400814Wijkman M, Lanne T, Ostgren CJ, Nystrom FH. Aortic pulse wave velocity predicts incident cardiovascular events in patients with type 2 diabetes treated in primary care. J Diabetes Complications. 2016 Sep-Oct;30(7):1223-8. doi: 10.1016/j.jdiacomp.2016.06.008. Epub 2016 Jun 19.
- Derived from this study: PubMed 26078787Jennersjo P, Guldbrand H, Bjorne S, Lanne T, Fredrikson M, Lindstrom T, Wijkman M, Ostgren CJ, Nystrom FH. A prospective observational study of all-cause mortality in relation to serum 25-OH vitamin D3 and parathyroid hormone levels in patients with type 2 diabetes. Diabetol Metab Syndr. 2015 Jun 12;7:53. doi: 10.1186/s13098-015-0049-9. eCollection 2015.
- Derived from this study: PubMed 25994184Vavruch C, Lanne T, Fredrikson M, Lindstrom T, Ostgren CJ, Nystrom FH. Serum leptin levels are independently related to the incidence of ischemic heart disease in a prospective study of patients with type 2 diabetes. Cardiovasc Diabetol. 2015 May 22;14:62. doi: 10.1186/s12933-015-0208-1.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Östgren, PhD study director
Linkoeping University
Fredrik H Nyström, Professor principal investigator
Linkoeping University
Toste Länne, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and Cardiovascular Diseases, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049737, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.