Type 2 Diabetes
Conditions
Interventions
Control Group:Metformin+lifestyle intervention
Intervention Group:?-3 fatty acid ethyl ester 90 soft capsules+metformin+lifestyle intervention
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, without gender restrictions. 2. Diagnosed with type 2 diabetes for at least 6 months. 3. Underwent dietary and exercise intervention within 3 months before enrollment and was on a stable dose of metformin monotherapy (=1500 mg or the maximum tolerated dose). 4. With metformin monotherapy, fasting plasma glucose =8 mmol/L and HbA1c between 6.5% and 8.0%. 5. Body Mass Index (BMI) between 18.5 kg/m² and 35 kg/m² (inclusive) at screening, with stable body weight (±10%) over the past 3 months. The participant agrees not to initiate weight-loss-specific dietary or exercise regimens during the study period, adhering only to lifestyle and dietary measures for diabetes management. 6. No use of ?-3 polyunsaturated fatty acid supplements in the 3 months preceding screening. 7. Signed informed consent and demonstrated good adherence.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes. 2. Intolerance or allergy to metformin or ?-3 fatty acids. 3. Use of GLP-1 receptor agonists (GLP-1RA), SGLT2 inhibitors (SGLT2i), DPP-4 inhibitors (DPP-4i), glucose kinase activators (GKA), insulin, or any other glucose-lowering agents besides metformin within the 3 months prior to screening. 4. Pregnant, breastfeeding, or planning pregnancy during the study period. 5. More than one episode of severe hypoglycemia in the 6 months prior to screening, or inadequate awareness of hypoglycemia symptoms and their management. 6. One or more episodes of ketoacidosis or hyperosmolar coma requiring hospitalization in the 6 months preceding screening. 7. History of proliferative retinopathy or macular disease confirmed by ophthalmological examination within 1.5 years prior to screening. 8. Estimated glomerular filtration rate (eGFR) 2.5 times the upper limit of normal (ULN) or total bilirubin >1.5 times ULN. 16. Blood transfusion or significant blood loss within 3 months prior to screening, known hemoglobinopathies, hemolytic anemia, sickle cell anemia, or hemoglobin levels <11 g/dL (men) or <10 g/dL (women), or any other known conditions that interfere with HbA1c measurement. 17. Active psychiatric disorders as determined by the investigator. 18. Use of any prescription or over-the-counter weight-loss medications or supplements with similar effects in the 3 months before screening. 19. Participation in another drug or device clinical study within 3 months before screening. 20. History of organ transplantation (excluding corneal transplantation) or currently awaiting an organ transplant. 21. Direct relatives of study investigators, defined as spouse, parents, children, or siblings, whether biological or legally adopted. 22. Other conditions deemed unsuitable for study participation by the investigator (including but not limited to social or familial circumstances that may hinder follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma docosahexaenoic acid (DHA) levels;Plasma eicosapentaenoic acid (EPA) levels;Total insulin secretion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The first phase of insulin release;Body composition analysis;carotid intima-media thickness;fundus examination;HbA1c;Blood lipids;fasting plasma glucose;fasting insulin;fasting C-peptide;complete blood count;urinalysis;liver function;Renal function analysis;urinary microalbumin;Safety Monitoring;dietary questionnaires;Complications of diabetes;The second phase of insulin release;electrocardiogram;Body Weight;Body Mass Index (BMI) ;Body Fat Percentage;Waist Circumference;Waist Circumference (WHR); | — |
Countries
China
Contacts
Public ContactYongfeng Song
Jinan Central Hospital
Outcome results
None listed