Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism

Zhejiang University

Status: Completed

Conditions: Type 2 Diabetes; Insulin Sensitivity; Cardiovascular Disease

Treatments: Dietary Supplement: triacylglycerol oil; Dietary Supplement: diacylglycerol oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01802541

P031217

Details and patient eligibility

About

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.

Enrollment: 127 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 2 patient groups, including a placebo group

DAG oil

Experimental group

Treatment:

Dietary Supplement: diacylglycerol oil

TAG oil

Placebo Comparator group

Treatment:

Dietary Supplement: triacylglycerol oil