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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duo li, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01802541
First received: February 27, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Insulin Sensitivity
Type 2 Diabetes
Cardiovascular Disease
Dietary Supplement: diacylglycerol oil
Dietary Supplement: triacylglycerol oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 120 days ]

Estimated Enrollment: 127
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAG oil Dietary Supplement: diacylglycerol oil
Placebo Comparator: TAG oil Dietary Supplement: triacylglycerol oil

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802541

Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Duo Li, Ph.D.
  More Information

No publications provided

Responsible Party: Duo li, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01802541     History of Changes
Other Study ID Numbers: P031217
Study First Received: February 27, 2013
Last Updated: February 28, 2013
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang University:
diacylglycerol oil
insulin sensitivity
type 2 diabetes
cardiovascular disease
risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 20, 2014