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RecruitingNCT06386939Updated Apr 26, 2024

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

An observational study in Type 2 Diabetes Mellitus With Complication, sponsored by Diabetes Foundation, India. Recruiting at 1 site in India. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Diabetes Foundation, India · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
300
Ages
20 Years to 70 Years
Sex
All
01

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:
  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%
Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus With Complication
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • With Acanthosis Nigricans

    T2DM with Acanthosis Nigricans

  • Without Acanthosis Nigricans

    T2DM Without Acanthosis Nigricans

05

What researchers measure

Primary outcomes

  1. Moderate to Severe Acanthosis Nigricans increases diabetes complications

    Time frame: 18 months

06

Study locations

1 of 1 sites recruiting
  • Anoop misra
    New Delhi, Delhi 110048, India
    • Anoop Misra, MD · Contact · anoopmisra@gmail.com · 01149101222
    • Koel Dutta, M.Sc · Contact · koelduttac@gmail.com · 01149101222
    • Anoop Misra, MD · Principal investigator
    • Koel Dutta, M.Sc · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06386939
Lead sponsor
Diabetes Foundation, India
Collaborators
National Diabetes Obesity and Cholesterol Foundation
Responsible party
Dr Anoop Misra (Director, Diabetes Foundation, India) — Principal investigator
First posted
Apr 26, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Oct 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Apr 26, 2024

Study contacts

Anoop Misra, MD
Contact
anoopmisra@gmail.com
01149101222
Anoop Misra, MD
principal investigator · National Diabetes Obesity and Cholesterol Foundation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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