Type II Diabetes Mellitus Without Mention of ComplicationDIABIMCAPNCT01898572
Carotid Atherosclerosis In Newly Diagnosed Type 2 Individuals
An observational study of Type II Diabetes Mellitus Without Mention of Complication, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
It has been hypothesized, based on recent trials, that only early intervention can reduce cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at early, or non-advanced, still modifiable disease… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Type II Diabetes Mellitus Without Mention of Complication
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jun 2015
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care area: 3 Primary care centers in the city center of Barcelona (Spain)
Who may be able to join
- Adult men and women older than 40 years and less than 75 years.
- Newly Diagnosed T2DM (NEWDM). NEWDM is a subject without previous history of diabetes who has laboratory evidence consistent with diabetes (American Diabetes Association) within the last year.
Who cannot join
- Previous cardiovascular events such as, but not limited to, myocardial infarction, acute coronary syndrome or chronic stroke, peripheral arterial disease, or revascularization surgery in any territory.
- Congestive heart failure (class III-IV).
- Cancer of any kind (except basal cell or for cervical carcinoma insitu) unless disease free is documented in the past five years.
- Anemia or known coagulopathy.
- Serum creatinine greater than 1.5 mg / dl or MDRD (Modification of Diet in Renal Disease) equation <50.
- Any organ transplant (except cornea)
Show all 15Show fewer
- Known HIV-positive, active tuberculosis, malaria, chronic viral hepatitis B or C, cirrhosis of any aetiology.
- Pregnant or gestational idea in the next 2-3 years to inclusion.
- History of alcohol dependence (or abusive consumption) or other drugs in the past five years.
- Psychiatric illness that would entail adherence problems.
- Participation in a clinical trial protocol or investigational drugs.
- Debilitating chronic illness or short life expectancy to prevent adherence or therapeutic intensification is not the goal of managing your diabetes.
- ECG signs of ischemic heart disease.
- Diabetes type 1 or anti-GAD antibody positive.
- Control population will be excluded based on the same criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carotid Intimae-media Thickness (CIMT) and Carotid Plaque (CP) Presence as Risk Markers of Cardiovascular Disease at the Time of Type 2 Diabetes Diagnosis
It has been hypothesized, based on recent trials, that only early intervention can reduce cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at early, or non-advanced, still modifiable disease stage. However, sparse information is available regarding atherosclerosis prevalence and its characteristics at diabetes presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major goal of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk factors, lack of adequate specificity to identify individuals at higher risk. Therefore, non-invasive tests, such as carotid ultrasound, have been recommended to better define CV risk in several groups of individuals, including those with intermediate risk or with T2DM.
This clinical study aims to improve the investigators knowledge on cardiovascular disease (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will show a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL) individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher risk in whom intervention should be more intensive.
Read more
Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM will be matched with CONTROL individuals, not only for age and sex (the main determinants of atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking habit.
The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study variables will be carotid ultrasound derived variables. The main aims of the study are: 1) to investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines) diabetes treatment.
Read the detailed description
Hypothesis:
In a Mediterranean population, the investigators hypothesized that the CIMT and the presence of carotid plaque (CP):
- Are higher in patients with newly diagnosed T2DM than in a control population before and after adjusting for cardiovascular risk factors,
- Can identify subjects with T2DM with increased cardiovascular risk at the beginning of the disease, and,
- Can identify subjects in whom subclinical cardiovascular disease progresses despite treatment of T2DM according to clinical practice.
Aims:
Primary objectives:
- To investigate differences in CIMT and the presence of CP in subjects with NEWDM and a control population. Cross-sectional study.
- To identify and characterize the subset of NEWDM subjects presenting an increased CIMT (greater than the mean + 1SD or ≥ P75th) or carotid plaque presence. Cross-sectional study
- To early characterize individuals in whom subclinical CVD worsens (CIMT progression ≥ mean + 1SD o ≥ P75th) even after multifactorial treatment of diabetes according to guidelines. Longitudinal study design with repeated measures.
Secondary objectives:
- To study the main determinants of CIMT and the CP presence in NEWDM subjects and a control population. In addition to the cardiovascular risk factors will be studied:
- association with Mediterranean diet biomarkers (serum and urine) and diet adherence (semiquantitative food frequency questionnaire)
- genetic determinants of CVD
- To investigate the main determinants of progression of CIMT in subjects treated according to clinical practice guidelines
- To investigate the association of baseline CIMT, its progression, and the presence of CP with clinical scores used to estimate cardiovascular risk. These scores are: REGICOR (Registre Gironí del Cor: the Gerona Heart Register), a calibrated Framingham Score for a Mediterranean population, low risk SCORE (Systematic Coronary Risk Evaluation), and the UKPDS (United Kingdom Prospective Diabetes Study) score (specific for T2DM).
- To identify carotid plaque biomarkers by a metabolomic approach
- Being tested
- Standard care
- Keywords
- Newly Diagnosed Type II Diabetes Mellitus, Carotid Intimae-media Thickness, Carotid Plaque, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Newly T2DM and control individuals will be controlled by their family care physician following standard (clinical guidelines) care.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed T2DM | Newly diagnosed T2DM with no CVD. Standard care. Receives: Other: Standard care | |
| Control individuals | Control individuals matched by age, gender, dyslipidemia, hypertension and smoking habit. Standard care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Plaque presence(CP)
To investigate CP prevalence differences between NEWDM and CONTROL subjects
Measured: Baseline
Carotid Intima Media Thickness (CIMT)
Compound CIMT (common carotid, bulb and internal carotid) differences between NEWDM and CONTROL.
Measured: Baseline
Secondary outcomes (4)
Changes in plaque height
Measured: Baseline to 18 months
Changes in CIMT at different territories
Measured: Baseline to 18 months
Changes in lifestyle
Mediterranean Diet adherence and physical activity (validated questionnaires)
Measured: Baseline to 18 months
CIMT
CIMT differences in different territories (common carotid, bulb and internal carotid) between NEWDM and CONTROL.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes Mellitus Without Mention of ComplicationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci d'Atenció Primària de Salut de l'Eixample
- Responsible party
- Principal investigator, Emilio Ortega Martínez de Victoria, Hospital Clinic of Barcelona
- Investigators
- Emilio Ortega, MD, PhD, Principal investigator, Hospital Clinic Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898572
- Sponsor's protocol ID
- PI11-DIABIMCAP
- Other IDs
- PI11/01723
- Acronym
- DIABIMCAP
- Status last verified
- Jun 2014
- First submitted
- 10 Jul 2013
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ray KK, Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, Erqou S, Sattar N. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009 May 23;373(9677):1765-72. doi: 10.1016/S0140-6736(09)60697-8.
PubMed 19465231Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
PubMed 20609967Nambi V, Chambless L, Folsom AR, He M, Hu Y, Mosley T, Volcik K, Boerwinkle E, Ballantyne CM. Carotid intima-media thickness and presence or absence of plaque improves prediction of coronary heart disease risk: the ARIC (Atherosclerosis Risk In Communities) study. J Am Coll Cardiol. 2010 Apr 13;55(15):1600-7. doi: 10.1016/j.jacc.2009.11.075.
PubMed 20378078Stork S, van den Beld AW, von Schacky C, Angermann CE, Lamberts SW, Grobbee DE, Bots ML. Carotid artery plaque burden, stiffness, and mortality risk in elderly men: a prospective, population-based cohort study. Circulation. 2004 Jul 20;110(3):344-8. doi: 10.1161/01.CIR.0000134966.10793.C9. Epub 2004 Jul 6.
PubMed 15238459Wagenknecht LE, Zaccaro D, Espeland MA, Karter AJ, O'Leary DH, Haffner SM. Diabetes and progression of carotid atherosclerosis: the insulin resistance atherosclerosis study. Arterioscler Thromb Vasc Biol. 2003 Jun 1;23(6):1035-41. doi: 10.1161/01.ATV.0000072273.67342.6D. Epub 2003 Apr 17.
PubMed 12702517Pencina MJ, D'Agostino RB Sr, Larson MG, Massaro JM, Vasan RS. Predicting the 30-year risk of cardiovascular disease: the framingham heart study. Circulation. 2009 Jun 23;119(24):3078-84. doi: 10.1161/CIRCULATIONAHA.108.816694. Epub 2009 Jun 8.
PubMed 19506114Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
PubMed 18784090ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.
PubMed 18539916Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
PubMed 18539917Greenland P, Alpert JS, Beller GA, Benjamin EJ, Budoff MJ, Fayad ZA, Foster E, Hlatky MA, Hodgson JM, Kushner FG, Lauer MS, Shaw LJ, Smith SC Jr, Taylor AJ, Weintraub WS, Wenger NK, Jacobs AK, Smith SC Jr, Anderson JL, Albert N, Buller CE, Creager MA, Ettinger SM, Guyton RA, Halperin JL, Hochman JS, Kushner FG, Nishimura R, Ohman EM, Page RL, Stevenson WG, Tarkington LG, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010 Dec 14;56(25):e50-103. doi: 10.1016/j.jacc.2010.09.001. No abstract available.
PubMed 21144964Bujosa F, Herreras Z, Catalan M, Pinyol M, Lamuela-Raventos RM, Martinez-Huelamo M, Gilabert R, Jimenez A, Ortega E, Chiva-Blanch G. Total carotene plasma concentrations are inversely associated with atherosclerotic plaque burden: A post-hoc analysis of the DIABIMCAP cohort. Clin Nutr. 2023 Jul;42(7):1168-1174. doi: 10.1016/j.clnu.2023.05.005. Epub 2023 May 13.
PubMed 37230851
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Intimae-media Thickness (CIMT) and Carotid Plaque (CP) Presence as Risk Markers of Cardiovascular Disease at the Time of Type 2 Diabetes Diagnosis
- ClinicalTrials.gov ID
- NCT01898572
- Acronym / sponsor ID
- DIABIMCAP / PI11-DIABIMCAP
- Keywords
- Newly Diagnosed Type II Diabetes Mellitus, Carotid Intimae-media Thickness, Carotid Plaque, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Consorci d'Atenció Primària de Salut de l'Eixample
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Jul 2013 (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.
It has been hypothesized, based on recent trials, that only early intervention can reduce cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This finding may imply that atherosclerosis at diabetes diagnosed, is either negligible, or at early, or non-advanced, still modifiable disease stage. However, sparse information is available regarding atherosclerosis prevalence and its characteristics at diabetes presentation. Furthermore, although cardiovascular disease (CVD) prevention is the major goal of treatment in T2DM, risk assessment tools, mostly based on traditional CV risk factors, lack of adequate specificity to identify individuals at higher risk. Therefore, non-invasive tests, such as carotid ultrasound, have been recommended to better define CV risk in several groups of individuals, including those with intermediate risk or with T2DM.
This clinical study aims to improve the investigators knowledge on cardiovascular disease (CVD) in subjects with newly diagnosed T2DM (NEWDM). The investigators hypothesis is that carotid ultrasound (carotid intimae media thickness [CIMT] and carotid plaque [CP]) will show a worse subclinical/preclinical CVD stage in NEWDM compared with non-diabetic (CONTROL) individuals. Moreover, carotid ultrasound will also identify T2DM individuals at a higher risk in whom intervention should be more intensive.
Because individuals with T2DM have a higher prevalence of several CV risk factors, NEWDM will be matched with CONTROL individuals, not only for age and sex (the main determinants of atherosclerosis), but also for known, treated hypertension and dyslipidemia, and smoking habit.
The investigators will study NEWDM and CONTROL individuals without clinical CVD. This is a cross-sectional and longitudinal (18 months of follow-up) case-control study. The main study variables will be carotid ultrasound derived variables. The main aims of the study are: 1) to investigate CIMT and CP prevalence differences between NEWDM and CONTROL subjects; 2) to characterize the subset of NEWDM subjects with a higher CIMT (≥ mean+1SD o ≥ P75th) or CP presence; and 3) to early characterize individuals in whom subclinical CVD worsens (CIMT progression ≥ mean + 1SD o ≥ P75th) even after standard (according to clinical guidelines) diabetes treatment.
Detailed description
Hypothesis:
In a Mediterranean population, the investigators hypothesized that the CIMT and the presence of carotid plaque (CP):
- Are higher in patients with newly diagnosed T2DM than in a control population before and after adjusting for cardiovascular risk factors,
- Can identify subjects with T2DM with increased cardiovascular risk at the beginning of the disease, and,
- Can identify subjects in whom subclinical cardiovascular disease progresses despite treatment of T2DM according to clinical practice.
Aims:
Primary objectives:
- To investigate differences in CIMT and the presence of CP in subjects with NEWDM and a control population. Cross-sectional study.
- To identify and characterize the subset of NEWDM subjects presenting an increased CIMT (greater than the mean + 1SD or ≥ P75th) or carotid plaque presence. Cross-sectional study
- To early characterize individuals in whom subclinical CVD worsens (CIMT progression ≥ mean + 1SD o ≥ P75th) even after multifactorial treatment of diabetes according to guidelines. Longitudinal study design with repeated measures.
Secondary objectives:
- To study the main determinants of CIMT and the CP presence in NEWDM subjects and a control population. In addition to the cardiovascular risk factors will be studied:
- association with Mediterranean diet biomarkers (serum and urine) and diet adherence (semiquantitative food frequency questionnaire)
- genetic determinants of CVD
- To investigate the main determinants of progression of CIMT in subjects treated according to clinical practice guidelines
- To investigate the association of baseline CIMT, its progression, and the presence of CP with clinical scores used to estimate cardiovascular risk. These scores are: REGICOR (Registre Gironí del Cor: the Gerona Heart Register), a calibrated Framingham Score for a Mediterranean population, low risk SCORE (Systematic Coronary Risk Evaluation), and the UKPDS (United Kingdom Prospective Diabetes Study) score (specific for T2DM).
- To identify carotid plaque biomarkers by a metabolomic approach
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed T2DM | – | Other: Standard careNewly diagnosed T2DM with no CVD. Standard care. |
| Control individuals | – | Other: Standard careControl individuals matched by age, gender, dyslipidemia, hypertension and smoking habit. Standard care. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care area: 3 Primary care centers in the city center of Barcelona (Spain)
Key inclusion criteria (2 listed)
- Adult men and women older than 40 years and less than 75 years.
- Newly Diagnosed T2DM (NEWDM). NEWDM is a subject without previous history of diabetes who has laboratory evidence consistent with diabetes (American Diabetes Association) within the last year.
Key exclusion criteria (15 listed)
- Previous cardiovascular events such as, but not limited to, myocardial infarction, acute coronary syndrome or chronic stroke, peripheral arterial disease, or revascularization surgery in any territory.
- Congestive heart failure (class III-IV).
- Cancer of any kind (except basal cell or for cervical carcinoma insitu) unless disease free is documented in the past five years.
- Anemia or known coagulopathy.
- Serum creatinine greater than 1.5 mg / dl or MDRD (Modification of Diet in Renal Disease) equation <50.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careNewly T2DM and control individuals will be controlled by their family care physician following standard (clinical guidelines) care. | Other | Control individuals, Newly diagnosed T2DM |
Primary outcome
Carotid Plaque presence(CP)
Time frame: Baseline
To investigate CP prevalence differences between NEWDM and CONTROL subjects
Carotid Intima Media Thickness (CIMT)
Time frame: Baseline
Compound CIMT (common carotid, bulb and internal carotid) differences between NEWDM and CONTROL.
4 secondary outcomes
Changes in plaque height
Time frame: Baseline to 18 months
Changes in CIMT at different territories
Time frame: Baseline to 18 months
Changes in lifestyle
Time frame: Baseline to 18 months
CIMT
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Background: PubMed 19465231Ray KK, Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, Erqou S, Sattar N. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009 May 23;373(9677):1765-72. doi: 10.1016/S0140-6736(09)60697-8.
- Background: PubMed 20609967Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
- Background: PubMed 20378078Nambi V, Chambless L, Folsom AR, He M, Hu Y, Mosley T, Volcik K, Boerwinkle E, Ballantyne CM. Carotid intima-media thickness and presence or absence of plaque improves prediction of coronary heart disease risk: the ARIC (Atherosclerosis Risk In Communities) study. J Am Coll Cardiol. 2010 Apr 13;55(15):1600-7. doi: 10.1016/j.jacc.2009.11.075.
- Background: PubMed 15238459Stork S, van den Beld AW, von Schacky C, Angermann CE, Lamberts SW, Grobbee DE, Bots ML. Carotid artery plaque burden, stiffness, and mortality risk in elderly men: a prospective, population-based cohort study. Circulation. 2004 Jul 20;110(3):344-8. doi: 10.1161/01.CIR.0000134966.10793.C9. Epub 2004 Jul 6.
- Background: PubMed 12702517Wagenknecht LE, Zaccaro D, Espeland MA, Karter AJ, O'Leary DH, Haffner SM. Diabetes and progression of carotid atherosclerosis: the insulin resistance atherosclerosis study. Arterioscler Thromb Vasc Biol. 2003 Jun 1;23(6):1035-41. doi: 10.1161/01.ATV.0000072273.67342.6D. Epub 2003 Apr 17.
- Background: PubMed 19506114Pencina MJ, D'Agostino RB Sr, Larson MG, Massaro JM, Vasan RS. Predicting the 30-year risk of cardiovascular disease: the framingham heart study. Circulation. 2009 Jun 23;119(24):3078-84. doi: 10.1161/CIRCULATIONAHA.108.816694. Epub 2009 Jun 8.
- Background: PubMed 18784090Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
- Background: PubMed 18539916ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.
- Background: PubMed 18539917Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
- Background: PubMed 21144964Greenland P, Alpert JS, Beller GA, Benjamin EJ, Budoff MJ, Fayad ZA, Foster E, Hlatky MA, Hodgson JM, Kushner FG, Lauer MS, Shaw LJ, Smith SC Jr, Taylor AJ, Weintraub WS, Wenger NK, Jacobs AK, Smith SC Jr, Anderson JL, Albert N, Buller CE, Creager MA, Ettinger SM, Guyton RA, Halperin JL, Hochman JS, Kushner FG, Nishimura R, Ohman EM, Page RL, Stevenson WG, Tarkington LG, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010 Dec 14;56(25):e50-103. doi: 10.1016/j.jacc.2010.09.001. No abstract available.
- Derived from this study: PubMed 37230851Bujosa F, Herreras Z, Catalan M, Pinyol M, Lamuela-Raventos RM, Martinez-Huelamo M, Gilabert R, Jimenez A, Ortega E, Chiva-Blanch G. Total carotene plasma concentrations are inversely associated with atherosclerotic plaque burden: A post-hoc analysis of the DIABIMCAP cohort. Clin Nutr. 2023 Jul;42(7):1168-1174. doi: 10.1016/j.clnu.2023.05.005. Epub 2023 May 13.
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.
Emilio Ortega, MD, PhD principal investigator
Hospital Clinic Barcelona (Spain)
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 Type II Diabetes Mellitus Without Mention of Complication, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Jun 2014. 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 Spain. 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?
Results are not available in the source record.
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?
Carotid Plaque presence(CP) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01898572, which also lists 11 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 25 Jun 2014.