Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Status:
Completed
Trial end date:
2020-02-18
Target enrollment:
Participant gender:
Summary
This D-LIFT (Effect of dulaglutide on Liver Fat) trial is an investigator initiated,
prospective, open label, randomized clinical study to examine the effect of dulaglutide 0.75
mg subcutaneously weekly for 4 weeks, followed by 1.5 mg weekly for 20 weeks when included in
the standard treatment for type 2 diabetes vs. standard treatment for type 2 diabetes (minus
dulaglutide) in patients with type 2 diabetes and NAFLD. Hepatic steatosis (intracellular fat
accumulation in hepatocytes) will be measured by MRI-PDFF, a validated quantitative biomarker
for liver fat. The study will be conducted according to the CONSORT guidelines. The patient
population for the trial will be derived from Medanta-The Medicity Hospital endocrine
out-patient clinic, who would primarily visit for management of type 2 diabetes and other
co-morbidities. The study will be conducted in Medanta-The Medicity Hospital, Gurugram,
Haryana, which is a tertiary care center in North India. Patients deemed eligible will be
screened for the trial. The clinical trial protocol will be presented for approval to the
institutional ethics review board. Informed written consent will be obtained from all the
participants before enrolment into the study.