Type II Diabetes MellitusNCT02446054
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
A study testing Musashino T2DM diet in people with Type II Diabetes Mellitus, run by Celio Technology Inc. at 1 site in Taiwan.
Trial summary
Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Musashino T2DM diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Dec 2015
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
- The subject is able to understand and comply with protocol requirements, instrument
- The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
- Signed and dated written informed consent
Who cannot join
- Pregnancy, breastfeeding or planning to become pregnant during the study
- Acute illness or infection requiring treatment within 14 days of study entry
- Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
- Presence of malignancies
- Participate in other clinical trial within 30 days prior to this study
- Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator)
- Concurrent significant medical condition that would limit ability to participate in the study
- Consider by the investigator to be unsuitable for study participation, for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control
Read the detailed description
In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Musashino T2DM diet
- Keywords
- T2DM, type II diabetes Mellitus, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musashino T2DM dietDietary supplement
provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
| Study group | Role | What they receive |
|---|---|---|
| One Arm Study | Experimental | provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period. Receives: Dietary Supplement: Musashino T2DM diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of glycosylated hemoglobin (HbA1c)
12 weeks diet control
Measured: 12 weeks
Secondary outcomes (6)
the change of patients' fasting blood Glucose
Measured: 12 weeks
the change of patients' fasting serum Insulin
Measured: 12 weeks
the change of patients' fasting serum C-peptide
Measured: 12 weeks
the change of EuroQol EQ-5D questionnaire
Measured: 12 weeks
the change of WHO-QoL questionnaire
Measured: 12 weeks
the patients' compliance questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celio Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CY Wang, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446054
- Sponsor's protocol ID
- 2013CMP-V2
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
1.Saydah SH, Eberhardt MS, Loria CM, Brancati FL. Age and the burden of death attributable to diabetes in the United States. Am J Epidemiol 2002;156:714-9. 2. Pastors JG, Franz MJ, Warshaw H, Daly A, Arnold MS. How effective is medical nutrition therapy in diabetes care? J Am Diet Assoc 2003;103:827-31. 3. American Diabetes Association, Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care 2008;31(Suppl 1):S61-78. 4. Robert E. Post, MD, MS, Arch G. Mainous III, PhD, Dana E. King, MD, MS, and Kit N. Simpson, DrPH Dietary Fiber for the Treatment of Type 2 Diabetes Mellitus: A Meta-Analysis J Am Board Fam Med 2012;25:16 -23.)
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
- ClinicalTrials.gov ID
- NCT02446054
- Acronym / sponsor ID
- 2013CMP-V2
- Conditions
- Type II Diabetes Mellitus
- Keywords
- T2DM, type II diabetes Mellitus, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Celio Technology Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 May 2015 (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.
Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control
Detailed description
In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Arm Study | Experimental | Dietary Supplement: Musashino T2DM dietprovide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
- The subject is able to understand and comply with protocol requirements, instrument
- The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
- Signed and dated written informed consent
Key exclusion criteria (8 listed)
- Pregnancy, breastfeeding or planning to become pregnant during the study
- Acute illness or infection requiring treatment within 14 days of study entry
- Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
- Presence of malignancies
- Participate in other clinical trial within 30 days prior to this study
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 |
|---|---|---|
| Musashino T2DM dietprovide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period. | Dietary supplement | One Arm Study |
Primary outcome
the change of glycosylated hemoglobin (HbA1c)
Time frame: 12 weeks
12 weeks diet control
6 secondary outcomes
the change of patients' fasting blood Glucose
Time frame: 12 weeks
the change of patients' fasting serum Insulin
Time frame: 12 weeks
the change of patients' fasting serum C-peptide
Time frame: 12 weeks
the change of EuroQol EQ-5D questionnaire
Time frame: 12 weeks
the change of WHO-QoL questionnaire
Time frame: 12 weeks
the patients' compliance questionnaire
Time frame: 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 28 Jan 2016.
- Background1.Saydah SH, Eberhardt MS, Loria CM, Brancati FL. Age and the burden of death attributable to diabetes in the United States. Am J Epidemiol 2002;156:714-9. 2. Pastors JG, Franz MJ, Warshaw H, Daly A, Arnold MS. How effective is medical nutrition therapy in diabetes care? J Am Diet Assoc 2003;103:827-31. 3. American Diabetes Association, Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care 2008;31(Suppl 1):S61-78. 4. Robert E. Post, MD, MS, Arch G. Mainous III, PhD, Dana E. King, MD, MS, and Kit N. Simpson, DrPH Dietary Fiber for the Treatment of Type 2 Diabetes Mellitus: A Meta-Analysis J Am Board Fam Med 2012;25:16 -23.)
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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.
CY Wang principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musashino T2DM diet in people with Type II Diabetes Mellitus, run by Celio Technology Inc. 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 8 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 28 Jan 2016. 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.
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?
the change of glycosylated hemoglobin (HbA1c) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02446054, which also lists 1 linked publication.
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 28 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.