Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386952
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-20
Brief Title:
To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump
Sponsor:
Diabetes Foundation India
Organization:
Diabetes Foundation India
Study Overview
Official Title:
To Compare People With T2DM Who Have Double Dorsal Cervical Fat Double Hump Versus Who do Not Have Double Dorsal Cervical Fat Double Hump
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 MildModSevere c Chronic Kidney Disease i MicroMacro albumin urea ii Increased Creatinine iii Decreased eGFR
Macro Vascular
1 Low ABIPAD
2 CVD-MIPTCACABGHeart Failure
3 CVS-Stroke TIACarotid Blockage 50
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 MildModSevere c Chronic Kidney Disease i MicroMacro albumin urea ii Increased Creatinine iii Decreased eGFR
Macro Vascular
1 Low ABIPAD
2 CVD-MIPTCACABGHeart Failure
3 CVS-Stroke TIACarotid Blockage 50
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 73
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 individuals current medications and medical history as well as conduct a physical examination
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 individuals current medications and medical history as well as conduct a physical examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None