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NCT01802541 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01802541
Other study ID # P031217
Secondary ID
Status Completed
Phase N/A
First received February 27, 2013
Last updated February 28, 2013

Study information
Verified date February 2013
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date
Est. primary completion date February 2006
Accepts healthy volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• diacylglycerol oil

• triacylglycerol oil

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Outcome
Type Measure Description Time frame Safety issue
Primary insulin resistance 120 days
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