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

Comparison of Micro- and Macrovascular Disease(s) in People With Type 2 Diabetes, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans

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:

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus With Complication

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Anoop Misra, MD; Phone Number: 01149101222; Email: anoopmisra@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110048
      • Recruiting
      • Anoop misra
      • Principal Investigator: Anoop Misra, MD
      • Contact: Anoop Misra, MD; Phone Number: 01149101222; Email: anoopmisra@gmail.com
      • Contact: Koel Dutta, M.Sc; Phone Number: 01149101222; Email: koelduttac@gmail.com
      • Sub-Investigator: Koel Dutta, M.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With Acanthosis Nigricans; T2DM with Acanthosis Nigricans
Without Acanthosis Nigricans; T2DM Without Acanthosis Nigricans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Moderate to Severe Acanthosis Nigricans increases diabetes complications	18 months

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: National Diabetes Obesity and Cholesterol Foundation
• Investigators: Principal Investigator: Anoop Misra, MD, National Diabetes Obesity and Cholesterol Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperpigmentation; Pigmentation Disorders; Melanosis; Diabetes Mellitus, Type 2; Diabetes Complications; Acanthosis Nigricans
• Other Study ID Numbers: 01/2024-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No