A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (\>5.5% as measured with magnetic resonance imaging (MRI))

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients

NCT03708887

Hyperglycaemia (Diabetic) Hyperlipidemias

COMPLETED NA

Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

NCT00323414

Fatty Liver

COMPLETED PHASE2

The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)

NCT03120299

Type 2 Diabetes Mellitus Hypertriglyceridemia

COMPLETED PHASE4

Fatty Acid Regulation of Platelet Function in Diabetes

NCT02373332

Thrombosis Type 2 Diabetes Mellitus

COMPLETED

Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women

NCT00371982

Type 2 Diabetes

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo matching to Omega-3 carboxylic acids (olive oil)

Placebo

Intervention Type DRUG

Placebo matching to dapagliflozin 10 mg

Omega-3 carboxylic acids 4g / day

Group Type EXPERIMENTAL

Omega-3 carboxylic acids

Intervention Type DRUG

4 g administered as 4 x 1 g capsules

Dapagliflozin, 10mg / day

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10 mg administered as 10 mg tablet

Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day

Group Type EXPERIMENTAL

Omega-3 carboxylic acids

Intervention Type DRUG

4 g administered as 4 x 1 g capsules

Dapagliflozin

Intervention Type DRUG

10 mg administered as 10 mg tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

Placebo matching to Omega-3 carboxylic acids (olive oil)

Intervention Type DRUG

Omega-3 carboxylic acids

4 g administered as 4 x 1 g capsules

Intervention Type DRUG

Dapagliflozin

10 mg administered as 10 mg tablet

Intervention Type DRUG

Placebo

Placebo matching to dapagliflozin 10 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture; Have liver fat content as assessed by MRI \>5.5%; Diagnosis of Type 2 diabetes since at least 6 months in accordance with WHO criteria.

Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history of positive islet antibodies); Creatinine clearance \<60 mL/min at screening (Cockcroft-Gault formula).

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No