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CTRI Number  CTRI/2024/05/067816 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   To compare people with T2DM who have double hump versus who do not have double hump. 
Scientific Title of Study   To compare people with T2DM who have double dorsal cervical fat (double hump) versus who do not have double dorsal cervical fat (double hump) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anoop Misra 
Designation  Chairman 
Affiliation  Fortis CDOC Hospital 
Address  Room No. 1, Diabetes and Endocrine department. B-16 Chirag Enclave Opp Devika Tower, Nehru Place

South
DELHI
110048
India 
Phone  01149101222  
Fax    
Email  anoopmisra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anoop Misra 
Designation  Chairman 
Affiliation  Fortis CDOC Hospital 
Address  Room No. 1, Diabetes and Endocrine department. B-16 Chirag Enclave Opp Devika Tower, Nehru Place


DELHI
110048
India 
Phone  01149101222  
Fax    
Email  anoopmisra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anoop Misra 
Designation  Chairman 
Affiliation  Fortis CDOC Hospital 
Address  Room No. 1, Diabetes and Endocrine department. B-16 Chirag Enclave Opp Devika Tower, Nehru Place


DELHI
110048
India 
Phone  01149101222  
Fax    
Email  anoopmisra@gmail.com  
 
Source of Monetary or Material Support  
Fortis CDOC Hospital B-16 Chirag Enclave, Opp Devika Tower, Nehru Place, New Delhi-110048 INDIA 
 
Primary Sponsor  
Name  National Diabetes Obesity and Cholesterol Foundation 
Address  C6/57 SDA New Delhi 110016 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anoop Misra  Fortis CDOC Hospital   Room No. 1, Diabetes and Endocrine department. B-16 Chirag Enclave Opp Devika Tower, Nehru Place
South
DELHI 
01149101222

anoopmisra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  .Patients with T2DM (up to 30 years Duration)
.BMI 25 to 40

 
 
ExclusionCriteria 
Details  .Alcoholic with Moderate to Severe.
.BMI greater than 40
.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.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Double Hump in people with T2D is associated with higher magnitude of diabetes-related complications than people with single hump or no hump  52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background:

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 (Anjana et al, 2011). 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% (Anjana et al,2017).

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.

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

 

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.

 

Methodology:

 

T2DM patient will be recruited from endocrine OPD

 

1.       Clinical History and Examination:

 

a.       General Physical Examination: Height, weight, waist circumference,

                                                      hip circumference, BMI, Blood Pressure, Hand grip.

                                                      Acanthosis Nigricans.

b.       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

(a) Low ABI/PAD

(b) CVD-MI/PTCA/CABG/Heart Failure

(c) CVS-Stroke/ TIA/Carotid Blockage >50%

 
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