Type 1 diabetes mellitus (T1DM)
Conditions
Interventions
Group 1:Placebo (corn oil)
Group 2:Omega-3 fatty acid ethyl ester 90 soft capsule (trade name: Lilexin)
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
12 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed T1DM for at least 1 year; 2. Aged range from 12 to 50 years; 3. Body Mass Index (BMI) : 16.0~28.0 kg/m^2; 4. Glycosylated hemoglobin (HbA1c) : 7-9.5%; 5. Signed written informed consent, able and willing to conduct daily self-glucose monitoring and regular follow-up for 6 months.
Exclusion criteria
Exclusion criteria: 1. Lactating and/or pregnant patients; 2. Taking Omega-3 polyunsaturated fatty acids within 3 months; 3. Allergies to fish or Omega-3 fatty acid supplements; 4. Complicated with acute infection; 5. Uncontrolled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=95mmHg); 6. Acute myocardial infarction occurred within 3 months; 7. Percutaneous coronary intervention, coronary artery bypass grafting, percutaneous endoplasty or vascular surgery should be performed within 1 month; 8. Active bleeding or hematological diseases (platelet count 177µmol/L or eGFR < 30 mL/min/1.73m^2); 11. Abnormal liver function (alanine aminotransferase or aspartate aminotransferase exceeding 1.5 times the upper limit of the reference range); 12. Long-term use of non-steroidal anti-inflammatory drugs other than aspirin; 13. A history of immunosuppressive and/or corticosteroid therapy; 14. Severe gastrointestinal disease; 15. History of malignant tumors (unless disease-free for 10 years or non-melanoma skin cancer); 16. Life expectancy <=12 months; 17. Patients addicted to drugs or other substances; 18. The investigator believes that the patient may not be able to complete the study or comply with the requirements of the study (for administrative reasons or otherwise).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose;Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Height;Body weight;Body mass index;Waist circumference;Hip circumference;Diabetic autoantibody titer;Insulin;C-peptide;Triglyceride;Cholesterol;Urea nitrogen;Creatinine;Uric acid;Albumin;Bilirubin;Glutamic-pyruvic transaminase;Glutamic oxaloacetic transaminase;TNF-a;IFN-?;Interleukin (IL); | — |
Countries
China
Contacts
Public ContactCong Li
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed