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临床试验/NCT02910271
NCT02910271已完成不适用

Clinical Features and Prevalence of Asymptomatic Peripheral Artery Disease in Patients With Type 1 Diabetes Mellitus

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal1 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
299
试验地点
1
主要终点
Prevalence of PAD in asymptomatic patients with T1DM assessed by ankle-branchial index.

研究概览

简要总结

AIMS: Determining the clinical features and prevalence of peripheral artery disease (PAD) in asymptomatics patients with type 1 diabetes mellitus (T1DM) and checking the validity of the current recommendations regarding for PAD screening in T1DM.

METHODOLOGY: An observational and cross-sectional prevalence study. The whole group of patients (sample size calculated: 299 patients) will make the Edinburgh Questionnaire for detecting classic symptoms of intermittent claudication, and after verifying the absence of symptoms and exclusion criteria, they will be included in the study. All patients will undergo assessment of clinical parameters related to T1DM and classic cardiovascular risk factors, as well as, an analytical assessment of the lipid profile, HbA1c level, proinflammatory profile and oxidative stress status. They will also undergo a comprehensive anthropometric assessment including office blood pressure (BP) monitoring and ambulatory 24-hours BP monitoring in patients with an indication as routine clinical practice, assessment of cardioautonomic function, and lastly an ankle-brachial index (ABI) by Doppler ultrasound, in the context of routine clinical practice in patients with clinical indication, or as an extraordinary procedure for participating in the study in patients who do not meet criteria for screening according to current recommendations.

详细描述

INTRODUCTION:

PAD is a condition characterized by atherosclerotic occlusive disease of the lower extremities. While PAD is a major risk factor for lower-extremity amputation, it is also accompanied by a high likelihood for symptomatic cardiovascular and cerebrovascular disease.

PAD is often more subtle in its presentation in patients with diabetes than in those without diabetes. In contrast to the focal and proximal atherosclerotic lesions of PAD found typically in other high-risk patients, in diabetic patients the lesions are more likely to be more diffuse and distal. Importantly, PAD in individuals with diabetes is usually accompanied by peripheral neuropathy with impaired sensory feedback, thus a classic history of claudication may be less common. Data from Framingham Heart Study revealed that 20% of PAD symptomatic patients had diabetes mellitus, but probably, this data greatly underestimates PAD prevalence. As well, it has been reported that of those with PAD, over one-half of patients are asymptomatic or have atypical symptoms, about one-third have claudication, and the rest have more severe disease. Also, patients with diabetes who have been identified with PAD are more prone to sudden ischemia secondary to arterial thrombosis or to have a pivotal event leading to neuroischemic ulceration or infection that rapidly results in an acute presentation with critical limb ischemia and risk of amputation.

However, is important to note, that most clinical data about PAD and diabetes, are becoming from population studies and randomized clinical trials, made up exclusively with type 2 patients, or more frequently, after analyzing all patients with diabetes diagnosis, without distinction between T1 to T2 subtypes. Thus, although much is known regarding PAD in the general population, the assessment and management of PAD in those with diabetes is less clear, especially in patients with T1DM diagnosis.

In 2003, a Consensus Development Conference was held regarding PAD in diabetes. After a series of lectures by experts in the field of endocrinology, cardiology, vascular surgery, orthopedic surgery, podiatry, and nursing, a vascular medicine panel was asked to answer questions about the epidemiology and impact of PAD in people with diabetes, diagnosis and treatment of PAD, but always generalizing the management of T1 and T2 diabetes, under the unique same term of "diabetes".

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous diagnosis of T1DM before 30 years of age.
  • DM diagnostic criteria:
  • DM cardinal symptoms (polyuria, polydipsia, unexplained weight loss) with plasma glucose ≥ 200 mg / dl, or diagnosis as diabetic ketoacidosis (DKA).
  • fasting plasma glucose (≥ 8 h) ≥ 126 mg / dl.
  • plasma glucose at 2 h in testing oral glucose tolerance test (75 g glucose) ≥ 200 mg / dl.
  • glycosylated hemoglobin (HbA1c) ≥ 6.5% [as certified by the National method Glycohemoglobin Standardized Program (NGSP) and standardized according to the Diabetes Control and Complication Trial trial (DCCT)].
  • The criteria b, c and d require confirmation, except in cases of hyperglycemia with acute decompensation (criteria a).
  • Positive determination of a autoantibody serum markers of immune destruction against antigens cytoplasm of the islet cells (ICA), anti-insulin (AAI), and / or anti protein glutamate decarboxylase (GADA) at initial diagnosis time or during the course of the disease.
  • Acceptance of participation in the study and sign the informed consent.

排除标准

  • Prior diagnosis of PAD, diabetic foot, leg amputation or symptoms in line with PAD according to the Edinburgh questionnaire for intermittent claudication.
  • Diagnosis of type 2 diabetes, gestational diabetes, latent autoimmune diabetes in adults (LADA) or maturity-onset diabetes of youth (MODY) diabetes.
  • Current pregnancy, institutionalized or terminal illness subjects.
  • Refusal to participate in the study or to sign the informed consent.

结局指标

主要结局

Prevalence of PAD in asymptomatic patients with T1DM assessed by ankle-branchial index.

时间窗: 2 years

次要结局

  • Association between homocysteine and asymptomatic artery disease in patients with type 1 diabetes mellitus.(2 years)
  • Number and percentage of patients with type 1 diabetes mellitus, cardiovascular autonomic dysfunction and asymptomatic PAD.(2 years)
  • Prevalence of asymptomatic atherosclerotic carotid disease in patients with asymptomatic PAD.(2 years)
  • Association between glycemic control and asymptomatic artery disease in patients with type 1 diabetes mellitus.(2 years)
  • Number and percentage of patients with pathological ankle-branchial index without screening criteria according to the current recommendations for subjects with type 1 diabetes mellitus.(2 years)
  • Association between anthropometric parameters and asymptomatic peripheral artery disease in patients with type 1 diabetes mellitus.(2 years)
  • Association between lipid profile and asymptomatic artery disease in patients with type 1 diabetes mellitus.(2 years)
  • Association between C-reactive protein and asymptomatic artery disease in patients with type 1 diabetes mellitus.(2 years)

研究者

研究点 (1)

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