| Registry | NCT01802541 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double |
| Enrollment | 127 (Estimated) |
| Sponsor | Zhejiang University (Other) |
| Conditions | Insulin Sensitivity, Type 2 Diabetes, Cardiovascular Disease |
| Interventions | diacylglycerol oil, triacylglycerol oil (Dietary supplement) |
| Dates | primary completion 2006-02-01, first posted 2013-03-01, last updated 2013-03-01 |
Related Papers Related Patents Related Grants Related Experts
All trials for Insulin Sensitivity All trials for Type 2 Diabetes All trials of diacylglycerol oil All trials of triacylglycerol oil
Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol levels and reduce body fat. The investigators hypothesize that replacing dietary fat with diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2 diabetic patients.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DAG oil | Experimental | Dietary Supplement: diacylglycerol oil | |
| TAG oil | Placebo comparator | Dietary Supplement: triacylglycerol oil |
Sex: All, ages: 40 Years to 70 Years
Inclusion Criteria: 1. Type 2 diabetic patients, blood sugar levels were stabilized between 7.0-10.0 mmol/L 2. Male, aged 40 - 70 years old, Female, aged post-menopausal - 70 years old. 3. Overweight/obese patients (BMI 25 - 40 kg/m2) 4. Currently under diet therapy for diabetes mellitus 5. Understands the procedures and willing to participate in the study Exclusion Criteria: 1. Patients who unwilling to give informed consent 2. Type 1 diabetic patients 3. Familial hyperlipemia patients or blood triacylglycerol concentration > 400 mg/dl 4. Patients with a history of cardiovascular disease and/or arteriosclerotic disease 5. Patients with a history of cerebrovascular disease 6. Patients with serious hepatic disease and/or renal disease 7. Patients with malignancy 8. Participation in another clinical study within 30 days prior to screening period. 9. Has a condition the doctor in charge believes would interfere with evaluation of the subject, or may put subject at undue risk