The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)
Condition: Type 2 Diabetes Mellitus; Hypertriglyceridemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      In the present study, patients with type 2 diabetes and hypertriglyceride will be enrolled
      from multiple centers in China. Randomization was computer generated and stratified by
      center. After screening, eligible subjects will be randomly assigned into one of the
      following two groups: Omega-3 fatty acids capsules ( 2pills bid) and placebo capsules (2pills
      bid).

      Blood, feces and urine samples will be collected before and after treatment. Triglycerides
      (TG), total cholesterol (TC), LDL-C, HDL-C, HbA1C, fasting plasma glucose (FPG), postprandial
      plasma glucose (PPG) will be measured. Blood metabolomics profiles of lipids, amino acids,
      bile acids, the change of gut microbiota, and pharmacogenomic components and parameters will
      be evaluated too.

      Sample Size Calculation:

      The primary clinical endpoint involves comparing changes in triglyceride (TG) levels between
      the placebo group and the omega-3 treatment group after a 12-week intervention. According to
      literature reports [Borthwick L J. The effects of an omega-3 ethyl ester concentrate on blood
      lipid concentrations in patients with hyperlipidaemia[J]. Clinical drug investigation, 1998,
      15(5): 397-404], following 12 weeks of n-3 or placebo-controlled treatment, patients with
      hypertriglyceridemia exhibited a 9.1±24.8% increase in the placebo group and a 28.3±19.1%
      decrease in the omega-3 treatment group (4g/day). Based on this data, we conservatively
      estimate no change in TG in the placebo group for this trial, while anticipating a 10%
      reduction in the omega-3 treatment group. With a combined standard deviation (SD) of 30%,
      α=0.05, β=0.2, we calculate the sample size based on the mean difference between the two
      groups, resulting in N1=N2=143 cases.

      Taking into account actual follow-up rates from preliminary research, we adjusted the
      estimated dropout rate from 20% to 5% and recalculated the sample size. Consequently, we plan
      to enroll 300 cases, with 150 in each of the omega-3 treatment and placebo groups,
      respectively.
    

Intervention name(s): Omega-3 fatty acid; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks; Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
Other intervention name(s): fish oil supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment