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

NCT06386952 | Recruiting

• 1 other identifier: 02/2024-2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.
2. 2.Complications Assessment: Patient will be analyzed for:
3. 3.Low ABI/PAD
4. 4.CVD-MI/PTCA/CABG/Heart Failure
5. 5.CVS-Stroke/ TIA/Carotid Blockage \>50%

Conditions

Type 2 Diabetes Mellitus With Complication

Outcome Measures

Primary Outcomes (1)

• Double Hump increases diabetes complications

  12 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with T2DM (up to 30 years Duration)
• Age 20 to 70 years
• BMI \>25 kg/m² to \>40 kg/m²
• Gender- Both (Male \& Female)

You may not qualify if:

• Alcoholic with Moderate to Severe.
• BMI \>40 kg/m²
• Congestive heart disease
• Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy.
• Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• National Diabetes Obesity and Cholesterol Foundation: collaborator

Study Sites (1)

Anoop misra

New Delhi, National Capital Territory of Delhi, 110048, India

RECRUITING

Study Officials

• Anoop Misra, MD

  National Diabetes Obesity and Cholesterol Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anoop Misra, MD

CONTACT

01149101222; anoopmisra@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)