Assessment of Liver Stiffness in non- obese patient with type 2 diabetes

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2023/06/054199

Lead Sponsor: NA

Brief Summary: The development of type 2 diabetes mellitus (T2DM) is a major public health problem in AsianIndians. Asian Indians develop T2DM at a younger age, and progresses faster than in other ethnicgroups. As a result, many diabetes complications are more prevalent and in more advanced stagesin Asian countries than in other regions. Asian Indians have one of the highest incidence rates ofpre-diabetes and T2DM among all major ethnic groups, and the conversion from pre-diabetes toT2DM occurs more rapidly in this population (1). According to the Indian Council of MedicalResearch-India diabetes study (n 57117), the prevalence of prediabetes in all 15 states was 7Â·3%(1).Non-alcoholic fatty liver disease (NAFLD) is accumulation of fat in liver in absence of significantalcohol consumption and other causes of liver diseases. It is estimated that 5-32% Asian Indianadult population have NAFLD (2). NAFLD is forerunner to obesity, prediabetes and T2DM. Theprevalence rate of NAFLD in T2DM was 12.5%-87.5% in India (3).Patients with T2DM are at increased risk of NAFLD and have a higher rate of mortality andprogression to cirrhosis (4). Further, high proportion of patients with NAFLD remainasymptomatic for long periods of time with normal liver tests, non-invasive procedures for earlyidentification of severe steatosis and advanced fibrosis / cirrhosis are necessary in T2DMpopulation. Limited number of studies have indicated that liver elastography is a valuablescreening tool for evaluating liver stiffness (5). In the present study we aim to examine the impactof diabetes on liver fibrosis and to see whether diabetes is a major cause for exacerbating theincidence of steatohepatitis and liver fibrosis.This prospective observational study will be of 6 monthsâ€™ duration where 100 T2DM patients fromurban areas of Delhi will be randomly screened. The population will be representative of differentsocio-economic strata of the society. Importantly, large cross sectional and prospective strategiesfor prevention of T2DM in Asian Indian population should focus on prediabetes, metabolicsyndrome and NAFLD.

Objectives: To assess Liver fibrosis in non-obese type 2 diabetes patients

Inclusion Criteria:1. Patients with T2DM (up to 15 years Duration)2. Age 25 to 60 years3. BMI < 25 kg/mÂ²4. Gender- Both5. USG finding showing definitive fatty liver

Exclusion Criteria:1. Chronic significant alcohol intake (> 20 gm/day)2. BMI > 25 kg/mÂ²3. Congestive heart disease4. Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg, consumption ofamiodarone and tamoxifen) and congestive hepatopathy.5. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy,major systemic illness etc.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patients with T2DM (up to 15 years Duration) 2.
Age 25 to 60 years 3.
BMI < 25 kg/mÂ² 4.
Gender- Both 5.
USG finding showing definitive fatty liver.

Exclusion Criteria

Chronic significant alcohol intake (> 20 gm/day) 2.
BMI > 25 kg/mÂ² 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.
Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To asses hepatic fat (by CAP) and hepatic fibrosis (by kPA) in Non obese patient with T2DM.	6 months

Secondary Outcome Measures

Name	Time	Method
To assess Liver fibrosis in non-obese type 2 diabetes patients	6 months

Trial Locations

Locations (1): Fortis CDOC Hospital
🇮🇳
South, DELHI, India
Fortis CDOC Hospital
🇮🇳South, DELHI, India
KANIKA TYAGI
Principal investigator
01149101222
tyg_knk@yahoo.com