type 2 diabetes mellitus
Conditions
Interventions
Intervention group:Daily oral krill oil capsules (500 mg/ capsule, 6 capsules, containing 3g krill oil)
Control group:Daily oral placebo
Sponsors
School of Public Health, Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, >=18 years old at the time of signing the informed consent; 2. Type 2 diabetes mellitus was diagnosed >=90 days before screening; 3. HbA1c 7.0-10.5% (53-91 mmol/mol)(both included), and stable for more than three months; 4. Subjects agreed to control blood sugar with standard treatment throughout the study period; 5. Subjects agreed to use effective contraception with their spouses throughout the study period and within 12 weeks of the last dose; 6. Before the test, understand in detail the nature, significance, possible benefits, possible inconveniences and potential dangers of the test, understand the research procedure and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to the test product or related products; 2. Women who are pregnant, breastfeeding, intending to become pregnant or have reproductive potential, and are not using an appropriate method of contraception (as required by local regulations or practices); 3. Receive any investigational drug within 90 days prior to screening; 4. Any obstacles that the investigator believes may jeopardize patient safety or compliance with the trial protocol; 5. Family or personal history of MEN2 or MTC; 6. History of pancreatitis (acute or chronic); 7. History of major surgical procedures involving the stomach that may affect the absorption of the test product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery); 8. Any of the following: myocardial infarction, stroke, or hospitalization for unstable angina and/or transient ischemic attack within 180 days prior to screening; 9. Patients requiring transplantation before randomization and during the trial; 10. HIV infection, hepatitis B infection, hepatitis C infection, or other active infections; 11. Patients with a history of malignant tumor or suspected tumor diagnosis; 12. Previous and current history of mental/psychological illness; 13. History of drug or alcohol abuse within 2 years prior to screening; 14. Any other diseases or conditions that the investigator deems inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Insulin;Insulin resistance index;C-Peptide;Blood routine examination; | — |
Countries
China
Contacts
Public ContactHao Wu
Department of Nutrition and Food Hygiene, School of Public Health, Shandong University
Outcome results
None listed