Carotid Atherosclerosis In Newly Diagnosed Type 2 Individuals

NCT01898572 | Unknown

• 2 other identifiers: PI11-DIABIMCAPPI11/01723
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type II Diabetes Mellitus Without Mention of Complication

Keywords

Newly Diagnosed Type II Diabetes Mellitus; Carotid Intimae-media Thickness; Carotid Plaque; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Carotid Plaque presence(CP)

  To investigate CP prevalence differences between NEWDM and CONTROL subjects

  Baseline

• Carotid Intima Media Thickness (CIMT)

  Compound CIMT (common carotid, bulb and internal carotid) differences between NEWDM and CONTROL.

  Baseline

Secondary Outcomes (4)

• Changes in plaque height

  Baseline to 18 months

• Changes in CIMT at different territories

  Baseline to 18 months

• Changes in lifestyle

  Baseline to 18 months

• CIMT

  Baseline

Other Outcomes (2)

• Changes in fat intake

  Baseline to 18 months

• Diet intake

  Baseline

Study Arms (2)

Newly diagnosed T2DM

Newly diagnosed T2DM with no CVD. Standard care.

Other: Standard care

Control individuals

Control individuals matched by age, gender, dyslipidemia, hypertension and smoking habit. Standard care.

Other: Standard care

Interventions

Standard care OTHER

Newly T2DM and control individuals will be controlled by their family care physician following standard (clinical guidelines) care.

Control individuals; Newly diagnosed T2DM

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care area: 3 Primary care centers in the city center of Barcelona (Spain)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Consorci d'Atenció Primària de Salut de l'Eixample: collaborator

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (11)

• 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.

  PMID: 19465231 BACKGROUND

• 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.

  PMID: 20609967 BACKGROUND

• 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.

  PMID: 20378078 BACKGROUND

• Stork 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.

  PMID: 15238459 BACKGROUND

• 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. doi: 10.1161/01.ATV.0000072273.67342.6D. Epub 2003 Apr 17.

  PMID: 12702517 BACKGROUND

• 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.

  PMID: 19506114 BACKGROUND

• 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.

  PMID: 18784090 BACKGROUND

• 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.

  PMID: 18539916 BACKGROUND

• 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.

  PMID: 18539917 BACKGROUND

• 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. No abstract available.

  PMID: 21144964 BACKGROUND

• Bujosa 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.

  PMID: 37230851 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, urine

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emilio Ortega, MD, PhD

  Hospital Clinic Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Endocrinologist, MD, PhD

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 12, 2013
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

ES (1)