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

NCT ID: NCT01802541

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Insulin Sensitivity Type 2 Diabetes Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DAG oil

Group Type EXPERIMENTAL

diacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

TAG oil

Group Type PLACEBO_COMPARATOR

triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

Interventions

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diacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

triacylglycerol oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Duo li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duo Li, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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P031217

Identifier Type: -

Identifier Source: org_study_id

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