Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945030
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-07-03
Brief Title:
Correlation of Xanthelasma With Atherosclerosis Hepatic Fat and Fibrosis
Sponsor:
Diabetes Foundation India
Organization:
Diabetes Foundation India
Study Overview
Official Title:
Association of Xanthelasma With Sub Clinical Atherosclerosis and Hepatic Fat A Case Control Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-07
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:
Patients with diabetes with clinical feature of Xanthelasma will show increased Atherosclerosis
Objectives
Primary
1 To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler
Secondary
2 To correlate xanthelasma to liver fat and fibrosis
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 Xanthelasma
2 Biochemical Test The biochemical analysis will be done using ELISA kit or commercially available kits
1 Fasting blood Glucose
2 Haemoglobin A1C The estimation of average blood sugar level over a period of two to three months will be analysed with the patients blood sample for haemoglobin A1C based on turbidimetric inhibition immunoassay method using COBAS 6000 analyser
3 Lipid Profile Fasting samples shall be analysed for lipid profile Levels of total cholesterol TC serum triglyceride TG and high-density lipoprotein cholesterol HDL-c will be estimated using commercial kits Randox Laboratory USA Value of low-density lipoprotein cholesterol LDL-c will be calculated according to Friedewalds equation
4 Liver Function Tests Fasting samples shall be analysed for liver function test Levels of alkaline phosphate Aspartate aminotransferase Alanine aminotransferase and Gamma-glutamyl transferase will be estimated by using commercial kits based on kinetic method
3 Assessment of sub-clinical atherosclerosis Pulse wave velocity and carotid Doppler will be done
1 Pulse wave velocity Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity
2 Carotid Doppler based on kinetic method
3 FibroScan Estimation It is a medical diagnostic tool Liver stiffness LSM in kPa and controlled attenuation parameter CAP in dBm measurements will be done by transient elastography FibroScan 430 Touch Echosens FR in order to quantify severity of liver fibrosis LSM 7-10 kPa for F1 101-13 for F2 and 13kPa for F3
Objectives
Primary
1 To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler
Secondary
2 To correlate xanthelasma to liver fat and fibrosis
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 Xanthelasma
2 Biochemical Test The biochemical analysis will be done using ELISA kit or commercially available kits
1 Fasting blood Glucose
2 Haemoglobin A1C The estimation of average blood sugar level over a period of two to three months will be analysed with the patients blood sample for haemoglobin A1C based on turbidimetric inhibition immunoassay method using COBAS 6000 analyser
3 Lipid Profile Fasting samples shall be analysed for lipid profile Levels of total cholesterol TC serum triglyceride TG and high-density lipoprotein cholesterol HDL-c will be estimated using commercial kits Randox Laboratory USA Value of low-density lipoprotein cholesterol LDL-c will be calculated according to Friedewalds equation
4 Liver Function Tests Fasting samples shall be analysed for liver function test Levels of alkaline phosphate Aspartate aminotransferase Alanine aminotransferase and Gamma-glutamyl transferase will be estimated by using commercial kits based on kinetic method
3 Assessment of sub-clinical atherosclerosis Pulse wave velocity and carotid Doppler will be done
1 Pulse wave velocity Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity
2 Carotid Doppler based on kinetic method
3 FibroScan Estimation It is a medical diagnostic tool Liver stiffness LSM in kPa and controlled attenuation parameter CAP in dBm measurements will be done by transient elastography FibroScan 430 Touch Echosens FR in order to quantify severity of liver fibrosis LSM 7-10 kPa for F1 101-13 for F2 and 13kPa for F3
Detailed Description:
T2DM is 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
Xanthelasma palpebrarum XP are yellow plaques that occur most commonly near the inner canthus of the eyelid and are often associated with atherosclerosis dyslipidaemia and coronary artery disease About 50 of patients who develop xanthelasma have lipid disorder It is commonly seen in patients with Type II hyperlipidaemia that includes type IIa also known as familial hypercholesterolemia and type IIb which is commonly referred to as familial combined hyperlipidaemia Type IV hyperlipidaemia which is also known as familial hypertriglyceridemia - Diabetes mellitus Hypothyroidism Those with low levels of HDL Fatty diet Excess alcohol intake Weight gain
A significant number of cases of xanthelasma palpebrarum are combined with smoking central obesity hypertension diabetes mellitus and dyslipidemia which are the major risk factors for CAD Efforts should be made to rule out the same in high-risk xanthelasma subjects
Patients with type 2 diabetes mellitus T2DM have a high cardiovascular risk even at young age There is a need to assess this increased risk and identify atherosclerosis early so that appropriate measures for risk reduction can be taken The Investigators aimed to study carotid-femoral pulse wave velocity Cf-PWV a non-invasive indicator of atherosclerosis in patients with diabetes below 50 years of age and its correlation with markers of obesity and other cardiovascular risk factors
Xanthelasma palpebrarum XP are yellow plaques that occur most commonly near the inner canthus of the eyelid and are often associated with atherosclerosis dyslipidaemia and coronary artery disease About 50 of patients who develop xanthelasma have lipid disorder It is commonly seen in patients with Type II hyperlipidaemia that includes type IIa also known as familial hypercholesterolemia and type IIb which is commonly referred to as familial combined hyperlipidaemia Type IV hyperlipidaemia which is also known as familial hypertriglyceridemia - Diabetes mellitus Hypothyroidism Those with low levels of HDL Fatty diet Excess alcohol intake Weight gain
A significant number of cases of xanthelasma palpebrarum are combined with smoking central obesity hypertension diabetes mellitus and dyslipidemia which are the major risk factors for CAD Efforts should be made to rule out the same in high-risk xanthelasma subjects
Patients with type 2 diabetes mellitus T2DM have a high cardiovascular risk even at young age There is a need to assess this increased risk and identify atherosclerosis early so that appropriate measures for risk reduction can be taken The Investigators aimed to study carotid-femoral pulse wave velocity Cf-PWV a non-invasive indicator of atherosclerosis in patients with diabetes below 50 years of age and its correlation with markers of obesity and other cardiovascular risk factors
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