Type II Diabetes Mellitus Without Mention of Complication Clinical Trial
— DIABIMCAPOfficial 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
| Verified date | June 2014 |
| Source | Hospital Clinic of Barcelona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | June 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion criteria: - 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) - 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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clinic of Barcelona | Barcelona | Cataluña |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Clinic of Barcelona | Consorci d'Atenció Primària de Salut de l'Eixample |
Spain,
Action 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. — View Citation
ADVANCE 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. — View Citation
Emerging 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. Erratum in: Lancet. 2010 Sep 18;376(9745):958. Hillage, H L [corrected to Hillege, H L]. — View Citation
Greenland 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. — View Citation
Holman 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. — View Citation
Nambi 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. — View Citation
Pencina 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. — View Citation
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. — View Citation
Störk 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. Epub 2004 Jul 6. — View Citation
Wagenknecht 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. Epub 2003 Apr 17. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Changes in fat intake | Blood cell membrane fatty acid composition was measured by gas chromatography | Baseline to 18 months | No |
| Other | Diet intake | Food frequency questionnaire Serum and urine biomarkers Blood cell membrane fatty acid composition | Baseline | No |
| Primary | Carotid Plaque presence(CP) | To investigate CP prevalence differences between NEWDM and CONTROL subjects | Baseline | No |
| Primary | Carotid Intima Media Thickness (CIMT) | Compound CIMT (common carotid, bulb and internal carotid) differences between NEWDM and CONTROL. | Baseline | No |
| Secondary | Changes in plaque height | Baseline to 18 months | No | |
| Secondary | Changes in CIMT at different territories | Baseline to 18 months | No | |
| Secondary | Changes in lifestyle | Mediterranean Diet adherence and physical activity (validated questionnaires) | Baseline to 18 months | No |
| Secondary | CIMT | CIMT differences in different territories (common carotid, bulb and internal carotid) between NEWDM and CONTROL. | Baseline | No |