Impaired Fasting GlucoseNCT01895387
Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
A study testing Dietary intervention-whole grains and legumes and Dietary intervention-Refined rice in people with Impaired Fasting Glucose and Newly Diagnosed Type 2 Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance… Read more about this study
- Who is it for?
- Ages 39 to 74 years
- Conditions the study is for
- Impaired Fasting Glucose, Newly Diagnosed Type 2 Diabetes
- What is being tested?
- Dietary intervention-whole grains and legumes and Dietary intervention-Refined rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Oct 2012
- 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 39 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose <126 mg/dL)
- or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)
Who cannot join
- current and/or past history of cardiovascular disease including angina
- liver or kidney dysfunction
- thyroid or pituitary disease
- unstable weight loss/gain (≥2 kg) over the previous 12 months
- pregnancy or lactation
- taking medications or supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.
Read the detailed description
Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.
- Being tested
- Dietary intervention-whole grains and legumes, Dietary intervention-Refined rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention-whole grains and legumesDietary supplement
Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
Dietary intervention-Refined riceDietary supplement
Subjects in the control group maintained their usual diet of refined rice
| Study group | Role | What they receive |
|---|---|---|
| Whole grains and legumes | Experimental | Not described Receives: Dietary Supplement: Dietary intervention-whole grains and legumes |
| Refined rice | Placebo comparator | Not described Receives: Dietary Supplement: Dietary intervention-Refined rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Lp-PLA2 activity
Measured: Change from baseline in Lp-PLA2 at 12 weeks
Secondary outcomes (1)
PBMC Lp-PLA2 activity
Measured: Change from baseline in PBMC Lp-PLA2 at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, Ph.D, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895387
- Sponsor's protocol ID
- FN20130614
- Status last verified
- Jul 2013
- First submitted
- 14 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01895387
- Acronym / sponsor ID
- FN20130614
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Jul 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.
We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.
Detailed description
Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grains and legumes | Experimental | Dietary Supplement: Dietary intervention-whole grains and legumes |
| Refined rice | Placebo comparator | Dietary Supplement: Dietary intervention-Refined rice |
Who may qualify
- Ages
- 39 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose <126 mg/dL)
- or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)
Key exclusion criteria (6 listed)
- current and/or past history of cardiovascular disease including angina
- liver or kidney dysfunction
- thyroid or pituitary disease
- unstable weight loss/gain (≥2 kg) over the previous 12 months
- pregnancy or lactation
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 |
|---|---|---|
| Dietary intervention-whole grains and legumesSubjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake. | Dietary supplement | Whole grains and legumes |
| Dietary intervention-Refined riceSubjects in the control group maintained their usual diet of refined rice | Dietary supplement | Refined rice |
Primary outcome
Plasma Lp-PLA2 activity
Time frame: Change from baseline in Lp-PLA2 at 12 weeks
1 secondary outcome
PBMC Lp-PLA2 activity
Time frame: Change from baseline in PBMC Lp-PLA2 at 12 weeks
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 10 Jul 2013.
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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.
Jong Ho Lee, Ph.D principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention-whole grains and legumes and Dietary intervention-Refined rice in people with Impaired Fasting Glucose and Newly Diagnosed Type 2 Diabetes, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Plasma Lp-PLA2 activity (time frame: Change from baseline in Lp-PLA2 at 12 weeks). 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 10 Jul 2013.