The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)
NCT03120299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 309
Last updated 2023-10-30
Summary
The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of lipid metabolism, especially of triglyceride after omega-3 administration in type 2 diabetes patients with hypertriglyceride.
Conditions
- Type 2 Diabetes Mellitus
- Hypertriglyceridemia
Interventions
- DRUG
-
Omega-3 fatty acid
Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
- DRUG
-
Placebos
Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
Sponsors & Collaborators
-
Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Guang Ning, MD, PHD · Ruijin Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2021-03-01
- Completion
- 2021-06-01
Countries
- China
Study Locations
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