Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Sponsors
Dr. Sanjeev Gulati
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: 1. Overweight (BMI >23) and obese Individuals diagnosed with type 1 or type II diabetes mellitus (T1DM & T2DM) in Central India. 2. Adult males and females aged from Age 18 to 35 years, both inclusive. 3. Willingness to provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1. History of excessive alcohol consumption (prescribed upper safe limit for men is up to 21 units of alcohol per week, and up to 14 units of alcohol for women. 1 unit is equal to 10 ml of absolute alcohol). 2. Presence of viral liver diseases (such as hepatitis B or C). 3. Presence of other known liver diseases apart from non-alcoholic fatty liver disease (NAFLD). 4. Women subject that are pregnant or lactating, or subject (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of 100 individuals between age of 18-35 years with Type 1 and Type2 diabetes with FIB 4 score and Fibroscan for presence of NAFLDTimepoint: This is a single point study where the young diabetic patients will be screened who qualify the inclusion criteria to assess the prevalence of NAFLD in young Diabetic patients. All the investigation including FIB 4 score on the basis of blood test and Fibroscan will be done on a single visit only. A total of 100 patients will be screened who qualify the inclusion criteria and the study will be concluded with the completion of 100 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the utility of combined method FIB -4 score & Fibroscan for diagnosis of NAFLD 2. To investigate potential hepatic complications & comorbidities associated with NAFLD in individuals with T1DM & T2DM. Timepoint: This is a single point study where the young diabetic patients will be screened who qualify the inclusion criteria to assess the prevalence of NAFLD in young Diabetic patients. All the investigation including FIB 4 score on the basis of blood test & Fibroscan will be done on a single visit only. A total of 100 patients will be screened who qualify the inclusion criteria & the study will be concluded with the completion of 100 patients. | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Sarvottam Hospital
Outcome results
None listed