protocolSection identificationModule nctId: NCT06373523, orgStudyIdInfo id: SHIELD, briefTitle: MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin, acronym: SHIELD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism., conditionsModule conditions: Hepatic Steato-Fibrosis, conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The placebo pills will be manufactured in identical appearance to the study drug (Dapagliflozin), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo, interventions name: Levothyroxine Replacement daily, outcomesModule primaryOutcomes measure: Change in liver fat content, secondaryOutcomes measure: Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography, secondaryOutcomes measure: Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months, secondaryOutcomes measure: Changes in Lipid Profile at 3 and 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PGIMER, city: Chandigarh, state: Punjab, zip: 160012, country: India, contacts name: ASHU RASTOGI, MD,DM, role: CONTACT, phone: 9781001046, phoneExt: 91, email: rastogi.ashu@pgi.ac.in, geoPoint lat: 30.73629, lon: 76.7884, hasResults: False