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Clinical Trials/CTRI/2019/05/019286
CTRI/2019/05/019286
Not Yet Recruiting
N/A

Efficacy and Safety of Dapagliflozin for reduction of steatohepatitis in patients of Type 2 diabetes with Nonalcoholic Steatohepatitis: A prospective, randomized, double-blinded, placebo-controlled study.

Dr Shashi Panicker0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Sponsor
Dr Shashi Panicker
Status
Not Yet Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Dr Shashi Panicker

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects who are willing and given their informed consent prior to any study\-specific prodedures.
  • •2\.Female or male aged 30 years or more
  • •3\. Recently diagnosed or known cases of type 2 diabetes
  • •4\.HbA1c above 7%
  • •5\.Presence of NASH
  • •6\.Fulfilment of criteria for non\-alcoholic fatty liver disease
  • •7\.eGFR \>45/ml/1\.73m squared

Exclusion Criteria

  • •1\.Diagnosis of Type 1 Diabetes
  • •2\.History of Bladder cancer
  • •3\.History of radiation therapy to the lower abdomen or pelvis at any time
  • •4\.Chronic cystitis and/ or recurrent urinary tract infections
  • •5\.Pregnant or breastfeeding women
  • •6\.Subjects with cirrhosis of the liver or obstructive biliary disease will be excluded.
  • •7\.Chronic Hepatitis B and hepatitis C
  • •8\.Subjects with alpha\-1 antitrypsin deficiency and Wilsonâ??s disease will be excluded.
  • •9\.Patients on Tamoxifen, methotrexate, amiodarone, thiazolidinediones, incretin mimetics like liraglutide and DPP4 inhibitors, or SGLT2 inhibitors like dapagliflozin, canagliflozin, or empagliflozin, will be excluded from the study.

Outcomes

Primary Outcomes

Not specified

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