CompletedNot Applicable

Effect of SGLT-2 Inhibitors in Patients With T2DM and Moderate to Severe Liver Fibrosis

India60 participantsStarted 2020-02-01

Plain-language summary

This retrospective study will be of 12 months duration where 40 T2DM patients coming to FORTIS C-DOC hospital in OPD with F3 fibrosis will be included in the study. The population will be representative of different socio-economic strata of the society. Clinical and dietary profiles, phenotypic markers (acanthosis nigricans, buffalo hump, skin tags, xanthelasma, double chin, arcus, hirsutism) anthropometric assessments body mass index; biochemical markers like liver function test, HbA1c, prothrombin time/INR, and fibroscan will be assessed.

Who can participate

Age range25 Years – 75 Years

SexALL

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Exclusion criteria

✕. Type 1 Diabetes
✕. Alcohol consumption per day (Men \>20 g and women \>10 g)
✕. Patients with Child B or Child C Cirrhosis
✕. Known case of HIV infection
✕. Congestive heart disease
✕. 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.

What they're measuring

Association between SGLT2i intake and hepatic fibrosis

Timeframe: 12 months

Trial details

NCT IDNCT05943899

SponsorDiabetes Foundation, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

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