To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump

To Compare People With T2DM Who Have Double Dorsal Cervical Fat (Double Hump) Versus Who do Not Have Double Dorsal Cervical Fat (Double Hump)

Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no hump

Objectives: To correlate single and double hump with diabetes complication 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. Buffalo Hump.
2. Complications Assessment: Patient will be analyzed 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).

"Buffalo hump," or a dorso cervical fat pad, is a term that refers to a collection of excess fat behind the neck that causes the shoulders to develop a hump-like shape. It can be caused by a variety of underlying conditions or medications.

A buffalo hump is most commonly a result of Cushing syndrome, a disorder of excess cortisol, a naturally occurring hormone that is involved in a variety of bodily processes, such as metabolism. High levels of the hormone cortisol can lead to increased fat synthesis. With Cushing syndrome, the fat produced often deposits in the neck, known as lipodystrophy. This produces the characteristic buffalo hump. Cushing syndrome may be caused by an adrenal tumor, lung tumor, or glucocorticoid medications. If Cushing syndrome is caused by a pituitary tumor, it is known as Cushing disease.

This Prospective observational study will be of 12 months' duration where 100 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.

To diagnose a buffalo hump and its underlying cause, a healthcare professional generally will review the individual's current medications and medical history, as well as conduct a physical examination.

• Study Type: Observational
• Enrollment (Estimated): 200

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)

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 Double Dorsal Cervical Fat; T2DM with Double Dorsal Cervical Fat (Double Hump)
Without Double Dorsal Cervical Fat; T2DM without Double Dorsal Cervical Fat (Double Hump)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Double Hump increases diabetes complications	12 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): May 31, 2025
• Study Completion (Estimated): June 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; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
• Other Study ID Numbers: 02/2024-2025

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