Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans

Last updated: April 24, 2024
Sponsor: Diabetes Foundation, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT06386939
01/2024-2025
  • Ages 20-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Methodology:

T2DM patient will be recruited from endocrine OPD

  1. Clinical History and Examination:

  2. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.

  3. 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

  1. Low ABI/PAD

  2. CVD-MI/PTCA/CABG/Heart Failure

  3. CVS-Stroke/ TIA/Carotid Blockage >50%

Eligibility Criteria

Inclusion

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

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. consumptionof amiodarone and tamoxifen) and congestive hepatopathy.
  5. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy,major systemic illness etc.

Study Design

Total Participants: 300
Study Start date:
May 01, 2024
Estimated Completion Date:
November 30, 2025

Study Description

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. 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%.

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.

Connect with a study center

  • Anoop misra

    New Delhi, Delhi 110048
    India

    Active - Recruiting

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