Type2diabetesNCT05945030
Correlation of Xanthelasma With Atherosclerosis, Hepatic Fat and Fibrosis
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Clinical Examination
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.
Who may be able to join
- Patients with T2DM
- Age 25 to 60 years
- BMI >25 kg/m² to >40 kg/m²
- Gender- Both (Male \& Female)
- Mild, moderate and severe Xanthelasma (Photograph)
Who cannot join
- Alcoholic abuse or other causes of liver dysfunction.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Fortis CDOC Hospital
Delhi, 110048
Anoop Misra, MD, 01149101222, anoopmisra@gmail.com
Koel Dutta, M.Sc, 01149101222, koelduttac@gmail.com
About this study
Official title: Association of Xanthelasma With Sub Clinical Atherosclerosis and Hepatic Fat: A Case Control Prospective Study
Patients with diabetes with clinical feature of Xanthelasma will show increased Atherosclerosis.
Objectives:
Read more
Primary
- To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler. Secondary
- To correlate xanthelasma to liver fat and fibrosis.
Methodology:
T2DM patient will be recruited from endocrine OPD
- Clinical History and Examination:
- General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Xanthelasma.
- Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
- Fasting blood Glucose
- Haemoglobin A1C: The estimation of average blood sugar level over a period of two to three months will be analysed with the patient's blood sample for haemoglobin A1C based on turbidimetric inhibition immunoassay method (using COBAS 6000 analyser)
- 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 Friedewald's equation.
- 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).
- Assessment of sub-clinical atherosclerosis: Pulse wave velocity and carotid Doppler will be done
- Pulse wave velocity: Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity.
- Carotid Doppler: (based on kinetic method)
- FibroScan Estimation: It is a medical diagnostic tool. Liver stiffness (LSM in kPa) and controlled attenuation parameter (CAP in dB/m) 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, 10.1-13 for F2 and >13kPa for F≥3
Read the 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 7·3%.
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.
- Conditions
- Type2diabetes
- Being tested
- Clinical Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ExaminationOther
T2DM patient visiting Fortis CDOC will undergo clinical examination to determine the grade of Xanthelasma.
| Study group | Role | What they receive |
|---|---|---|
| With Xanthelasma | T2DM with Xanthelasma Receives: Other: Clinical Examination | |
| Without Xanthelasma | T2DM without Xanthelasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine correlation of Xanthelasma with Pulse wave velocity, Carotid Doppler scores and Fibrosis
Patient with T2DM and Xanthelasma have a high risk of atherosclerosis.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, Fortis CDOC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945030
- Sponsor's protocol ID
- 2023-24/01
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Xanthelasma With Sub Clinical Atherosclerosis and Hepatic Fat: A Case Control Prospective Study
- ClinicalTrials.gov ID
- NCT05945030
- Acronym / sponsor ID
- 2023-24/01
- Conditions
- Type2diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with diabetes with clinical feature of Xanthelasma will show increased Atherosclerosis.
Objectives:
Primary
- To correlate xanthelasma and its severity to pulse wave velocity and atherosclerosis as see in carotid doppler. Secondary
- To correlate xanthelasma to liver fat and fibrosis.
Methodology:
T2DM patient will be recruited from endocrine OPD
- Clinical History and Examination:
- General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Xanthelasma.
- Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
- Fasting blood Glucose
- Haemoglobin A1C: The estimation of average blood sugar level over a period of two to three months will be analysed with the patient's blood sample for haemoglobin A1C based on turbidimetric inhibition immunoassay method (using COBAS 6000 analyser)
- 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 Friedewald's equation.
- 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).
- Assessment of sub-clinical atherosclerosis: Pulse wave velocity and carotid Doppler will be done
- Pulse wave velocity: Arterial stiffness indices will be analyzed by measuring carotid femoral pulse wave velocity.
- Carotid Doppler: (based on kinetic method)
- FibroScan Estimation: It is a medical diagnostic tool. Liver stiffness (LSM in kPa) and controlled attenuation parameter (CAP in dB/m) 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, 10.1-13 for F2 and >13kPa for F≥3
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 7·3%.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Xanthelasma | – | Other: Clinical ExaminationT2DM with Xanthelasma |
| Without Xanthelasma | – | –T2DM without Xanthelasma |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.
Key inclusion criteria (5 listed)
- Patients with T2DM
- Age 25 to 60 years
- BMI >25 kg/m² to >40 kg/m²
- Gender- Both (Male \& Female)
- Mild, moderate and severe Xanthelasma (Photograph)
Key exclusion criteria (2 listed)
- Alcoholic abuse or other causes of liver dysfunction.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical ExaminationT2DM patient visiting Fortis CDOC will undergo clinical examination to determine the grade of Xanthelasma. | Other | With Xanthelasma |
Primary outcome
To determine correlation of Xanthelasma with Pulse wave velocity, Carotid Doppler scores and Fibrosis
Time frame: 12 month
Patient with T2DM and Xanthelasma have a high risk of atherosclerosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop Misra, MD principal investigator
Fortis CDOC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01149101222, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine correlation of Xanthelasma with Pulse wave velocity, Carotid Doppler scores and Fibrosis (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.