Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

What Was Tested

The trial (not phased) is built around Dulaglutide for fatty liver & elevated liver enzymes.

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.

It had two arms (groups): Dulaglutide group (experimental) and Control group (no intervention).

Receive standard treatment for type 2 diabetes and up titration of treatment will be done by anti-diabetic medicines other than the GLP-1 receptor agonist.

The registry classes the interventions as drug.

More on the Plan

OBJECTIVE Nonalcoholic fatty liver disease (NAFLD) is a public health problem in patients with type 2 diabetes mellitus (T2DM).

The presence of type 2 diabetes in patients with NAFLD is a risk factor for its progression to a more severe liver disease known as nonalcoholic steatohepatitis (NASH).

NASH, in turn, can progress to liver fibrosis, cirrhosis and hepatocellular cancer in some patients.

Dulaglutide is a weekly injectable GLP-1 receptor agonist that is approved for type 2 diabetes.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all of the following two criteria:. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: history of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; thyroid stimulating hormone (tsh) value that is either \< 0.45 miu/l or \>10 miu/l at screening; BMI ≥23 kg/m2 or ≤40 kg/m2.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the fatty liver & elevated liver enzymes participants, was kept unaware of whether Dulaglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-01-01 with completion listed for 2020-01-14.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in liver fat (time frame: Baseline to 24 weeks).

It also tracked 6 secondary outcomes, for example Change in Biochemical Markers, Change in Fibroscan Parameters, Change in Fibroscan Parameters, change in cardiometabolic markers, Change in Biochemical Markers and Change in Biochemical Markers.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Dulaglutide in 60 people with fatty liver & elevated liver enzymes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, Fatty liver & elevated liver enzymes research.