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临床试验/CTRI/2024/05/067815
CTRI/2024/05/067815尚未招募不适用

To compare micro vascular and macro vascular disease in patient with Diabetes, who have moderate to severe Acanthosis Nigricans versus those who do not have Acanthosis Nigricans

National Diabetes Obesity and Cholesterol Foundation1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年5月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication(s)

研究概览

简要总结

Background:

The development of type 2 diabetes mellitus (T2DM) as a major public health problem in Asian Indians. Asian Indians develop T2DM at a younger age, and progresses faster than in other ethnic groups. As a result, many diabetes complications are more prevalent and in more advanced stages in Asian countries than in other regions. Asian Indians have one of the highest incidence rates of pre-diabetes and T2DM among all major ethnic groups, and the conversion from pre-diabetes to T2DM occurs more rapidly in this population (Anjana et al, 2011). According to the Indian Council of Medical Research- India diabetes study (57 117 individuals), the prevalence of prediabetes in all 15 states was 7·3% (Anjana et al,2017).

The tendency of Asian Indian to develop T2DM is enhanced by greater insulin resistance, dysglycemia, subclinical inflammation and non-alcoholic fatty liver disease (NAFLD).

 Acanthosis nigricans (AN) describes clinically a darkly pigmented thickening skin, which produces epidermal and dermal hyperplasia with orthokeratotic hyperkeratosis and papillomatosis of the stratum spinosum with basal layer hyperpigmentation, in the absence of actual acanthosis and melanocytosis on histologic examination. It is a reactive cutaneous change closely associated with obesity, insulin resistance, and hyperinsulinemia; endocrinopathy; or malignancy, in particular gastrointestinal adenocarcinoma. The prevalence varies, and ethnicity seems an independent factor. Evidence indicates that AN is a useful clinical marker to identify patients susceptible to insulin resistance, the MetS, and type 2 diabetes (T2DM).

 This Prospective observational study will be of 12-18 months’ duration where 150 T2DM patients from urban areas of Delhi will be randomly screened. The population will be representative of different socio-economic strata of the society. Clinical and dietary profiles, blood pressure and phenotypic markers (acanthosis nigricans, buffalo hump, skin tags: xanthelasma, double chin, arcus, hirsutism and tendon xanthoma), diabetic retinopathy, peripheral arterial disease (PAD), neuropathy, nephropathy HTN, CHF, CT Coronary Angiography, CAD, Arrhythmias, Coronary Calcification, Cerebrovascular Disease, peripheral vascular disease, micro albumin urea, fibro scan and hand grip (average of three values) JAMAR measurement will be assessed.

Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.

 Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complication

Inclusion Criteria:

1.       Patients with T2DM (up to 30 years Duration)

2.       Age 20 to 70 years

3.       BMI >25 kg/m² to >40 kg/m²

4.       Gender- Both (Male & Female)

5.       Mild, Moderate and Severe Acanthosis

 Exclusion Criteria:

1.       Alcoholic with Moderate to Severe.

2.       BMI >40 kg/m²

3.       Congestive heart disease

4.       Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy.

**5.**Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

 Methodology:

T2DM patient will be recruited from endocrine OPD

1.       Clinical History and Examination:

 a.       General Physical Examination: Height, weight, waist circumference,

hip circumference, BMI, Blood Pressure, Hand grip.

Acanthosis Nigricans.

b.       Complications Assessment: Patient will be analysed for:

 Micro Vascular

(a) Diabetic retinopathy

(i) Mild NPDR

(ii) Mod NPDR

(iii) Macular Edema / CSME

(b) Neuropathy (Mild/Mod/Severe)

(c) Chronic Kidney Disease

(i) Micro/Macro albumin urea

(ii) Increased Creatinine

(iii) Decreased eGFR

 Macro Vascular

(a) Low ABI/PAD

(b) CVD-MI/PTCA/CABG/Heart Failure

(c) CVS-Stroke/ TIA/Carotid Blockage >50%

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • .Patients with T2DM (up to 30 years Duration) .BMI 25 to 40 .Mild Moderate and Severe Acanthosis.

排除标准

  • Chronic significant alcohol intake.
  • BMI ≥40 kg/m² .
  • Chronic Smoker .
  • Suffering from end stage disease .
  • Suffering from chronic infections (e.g. tuberculosis).

结局指标

主要结局

Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication(s)

时间窗: 18 months

次要结局

  • NA(NA)

研究者

发起方
National Diabetes Obesity and Cholesterol Foundation
申办方类型
Other [trust]
责任方
Principal Investigator
主要研究者

Dr Anoop Misra

Fortis CDOC Hospital

研究点 (1)

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