Insulin SensitivityNCT01802541
Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism
A study testing diacylglycerol oil and triacylglycerol oil in people with Insulin Sensitivity and Type 2 Diabetes, run by Zhejiang University.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Insulin Sensitivity, Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- diacylglycerol oil and triacylglycerol oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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.
- Conditions
- Insulin Sensitivity, Type 2 Diabetes, Cardiovascular Disease
- Being tested
- diacylglycerol oil, triacylglycerol oil
- Keywords
- diacylglycerol oil, insulin sensitivity, type 2 diabetes, cardiovascular disease, risk factors
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diacylglycerol oilDietary supplement
triacylglycerol oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DAG oil | Experimental | Not described Receives: Dietary Supplement: diacylglycerol oil |
| TAG oil | Placebo comparator | Not described Receives: Dietary Supplement: triacylglycerol oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duo li, Zhejiang University
- Investigators
- Duo Li, Ph.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802541
- Sponsor's protocol ID
- P031217
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism
- ClinicalTrials.gov ID
- NCT01802541
- Acronym / sponsor ID
- P031217
- Conditions
- Insulin Sensitivity, Type 2 Diabetes, Cardiovascular Disease
- Keywords
- diacylglycerol oil, insulin sensitivity, type 2 diabetes, cardiovascular disease, risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Primary completion
- Feb 2006 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAG oil | Experimental | Dietary Supplement: diacylglycerol oil |
| TAG oil | Placebo comparator | Dietary Supplement: triacylglycerol oil |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diacylglycerol oil | Dietary supplement | DAG oil |
| triacylglycerol oil | Dietary supplement | TAG oil |
Primary outcome
insulin resistance
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
Related trials for Insulin Sensitivity
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duo Li, Ph.D. principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing diacylglycerol oil and triacylglycerol oil in people with Insulin Sensitivity and Type 2 Diabetes, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.