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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Insulin Sensitivity; Cardiovascular Disease
• Interventions: Dietary Supplement: diacylglycerol oil; Dietary Supplement: triacylglycerol oil

• Registration Number: NCT01802541
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Primary Completion: 2006-02
• Status Verified: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Last Update Submitted: 2013-02-28
• Study First Posted: 2013-03-01
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAG oil	diacylglycerol oil	-
TAG oil	triacylglycerol oil	-

Primary Outcome Measures

Name	Time	Method
insulin resistance	120 days