Diabetes MellitusPhase 4NCT00337337
Multiple Grain in Type 2 Diabetes
A Phase 4 study testing Multiple grain and Ordinary Asian- rice in people with Diabetes Mellitus, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile in these patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Multiple grain and Ordinary Asian- rice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to Feb 2007
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in inadequate but stable glycemic control by diet. Inadequate glycemic control isdefined as: HbA1c 7.1-11.0%
- Patients have signed the written informed consent.
Who cannot join
- Patients with type 1 diabetes mellitus
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
- Patients with impaired kidney function (serum creatinine>3.0 mg/dl)
- Patients with emphysema or chronic bronchitis
- Patients with hepatic cirrhosis
Show all 9Show fewer
- Patients with chronic intestinal diseases related to marked disorders of digestion or absorption
- Patients participated investigational drug trial within 1 month before entering this study
- Patients with any other serious diseases considered by the investigator not in the condition to enter the trial
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
H-Y Ou, MD
About this study
Official title: Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
We aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile in these patients.
Read the detailed description
Resistance of insulin-mediated glucose transport is a fundamental early defect in the pathogenesis of type 2 diabetes mellitus (DM). It has been found that high fiber concentration in meal is frequently associated with low GI. In many single-blind cross-over study, short term consumption of high fiber meal has been shown to enhance postprandial insulin sensitivity in healthy subjects. We presume that increasing daily consumption of fiber would improve the insulin resistance and therefor glycemic parameters patients with DM. Patients with type 2 diabetes with stable dose of hypoglycemic medication control will be recruited, two types of meals will be given, type A is a general Asian rice-meal and type B consists of the same rice with multiple-grain-fiber added. Both type of meals will be consumed for 3 months by each patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Multiple grain, Ordinary Asian- rice
- Keywords
- Diabetes, rice, fiber
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple grainBehavioural
Ordinary Asian- riceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile
Secondary outcomes (2)
Changes in body weight
Acceptabiliy and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startApr 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- T-J Wu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337337
- Sponsor's protocol ID
- NCKU-94-032
- Status last verified
- Jun 2006
- First submitted
- 14 Jun 2006
- Last updated
- 18 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reconstitute Multiple Grain on Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00337337
- Acronym / sponsor ID
- NCKU-94-032
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, rice, fiber
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Feb 2007
- First posted
- 15 Jun 2006 (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 aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. We anticipate this intervention will improve glycemia and lipid profile in these patients.
Detailed description
Resistance of insulin-mediated glucose transport is a fundamental early defect in the pathogenesis of type 2 diabetes mellitus (DM). It has been found that high fiber concentration in meal is frequently associated with low GI. In many single-blind cross-over study, short term consumption of high fiber meal has been shown to enhance postprandial insulin sensitivity in healthy subjects. We presume that increasing daily consumption of fiber would improve the insulin resistance and therefor glycemic parameters patients with DM. Patients with type 2 diabetes with stable dose of hypoglycemic medication control will be recruited, two types of meals will be given, type A is a general Asian rice-meal and type B consists of the same rice with multiple-grain-fiber added. Both type of meals will be consumed for 3 months by each patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in inadequate but stable glycemic control by diet. Inadequate glycemic control isdefined as: HbA1c 7.1-11.0%
- Patients have signed the written informed consent.
Key exclusion criteria (9 listed)
- Patients with type 1 diabetes mellitus
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
- Patients with impaired kidney function (serum creatinine>3.0 mg/dl)
- Patients with emphysema or chronic bronchitis
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 |
|---|---|---|
| Multiple grain | Behavioural | – |
| Ordinary Asian- rice | Behavioural | – |
Primary outcome
Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile
2 secondary outcomes
Changes in body weight
Acceptabiliy and tolerability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2006.
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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.
T-J Wu, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multiple grain and Ordinary Asian- rice in people with Diabetes Mellitus, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Oct 2006. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HY Ou, MD (886-6-2353535 ext. 2177, wahoryi@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycemic parameters including fasting plasma glucose, postprandial plasma glucose, insulin sensitivity and lipid profile. 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 18 Oct 2006; AzTrials last refreshed its copy on 3 Nov 2026.