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

February 28, 2013 updated by: Duo li, Zhejiang University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

127

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAG oil
Dietary supplement: diacylglycerol oil
Placebo Comparator: TAG oil
Dietary supplement: triacylglycerol oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin resistance
Time Frame: 120 days
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Duo Li, Ph.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P031217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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