NCT01802541

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

First QC Date

February 27, 2013

Last Update Submit

February 28, 2013

Conditions

Insulin SensitivityType 2 DiabetesCardiovascular Disease

Keywords

diacylglycerol oilinsulin sensitivitytype 2 diabetescardiovascular diseaserisk factors

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    120 days

Study Arms (2)

DAG oil

EXPERIMENTAL
Dietary Supplement: diacylglycerol oil

TAG oil

PLACEBO COMPARATOR
Dietary Supplement: triacylglycerol oil

Interventions

diacylglycerol oilDIETARY_SUPPLEMENT
DAG oil
triacylglycerol oilDIETARY_SUPPLEMENT
TAG oil

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients, blood sugar levels were stabilized between 7.0-10.0 mmol/L
  • Male, aged 40 - 70 years old, Female, aged post-menopausal - 70 years old.
  • Overweight/obese patients (BMI 25 - 40 kg/m2)
  • Currently under diet therapy for diabetes mellitus
  • Understands the procedures and willing to participate in the study

You may not qualify if:

  • Patients who unwilling to give informed consent
  • Type 1 diabetic patients
  • Familial hyperlipemia patients or blood triacylglycerol concentration \> 400 mg/dl
  • Patients with a history of cardiovascular disease and/or arteriosclerotic disease
  • Patients with a history of cerebrovascular disease
  • Patients with serious hepatic disease and/or renal disease
  • Patients with malignancy
  • Participation in another clinical study within 30 days prior to screening period.
  • Has a condition the doctor in charge believes would interfere with evaluation of the subject, or may put subject at undue risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

DiglyceridesTriglycerides

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GlyceridesLipids

Study Officials

  • Duo Li, Ph.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Primary Completion

February 1, 2006

Last Updated

March 1, 2013

Record last verified: 2013-02