Diabetes MellitusJEDISNCT00464594
Japan Early Diabetes Intervention Study
A study testing Standard lifestyle guidance, Lifestyle guidance and monotherapy with acarbose and Lifestyle guidance and monotherapy with metformin in people with Diabetes Mellitus, run by Japan Early Diabetes Intervention Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide). Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Standard lifestyle guidance, Lifestyle guidance and monotherapy with acarbose and Lifestyle guidance and monotherapy with metformin
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,560 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to not given
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9%
Who cannot join
- Type 1 diabetes mellitus
- Undergoing treatment with steroids
- Secondary diabetes mellitus
- Diabetes mellitus due to suspected gene abnormalities
- BMI >= 35 kg/m2 or BMI < 18.5 kg/m2
- Undergone a surgery
Show all 19Show fewer
- Severe hyperuricemia (gout) associated with organ dysfunction
- Severe vascular diseases with organ dysfunction
- Cancer or other malignant neoplasms
- Liver cirrhosis or chronic hepatic, chronic renal failure
- Gastrointestinal disorders
- Always performing rigorous muscular exercise
- Severe infection or serious trauma
- Women who are pregnant
- Alcohol dependence or drug dependence
- Drug allergy
- Anemic
- Abnormal hemoglobinuria
- Severe mental disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tokyo Medical and Dental University
Tokyo, 113-8519
03-3813-6111
About this study
Official title: A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).
Read the detailed description
In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.
- Conditions
- Diabetes Mellitus
- Being tested
- Standard lifestyle guidance, Lifestyle guidance and monotherapy with acarbose, Lifestyle guidance and monotherapy with metformin, Lifestyle guidance and monotherapy with gliclazide
- Keywords
- Japan Early Diabetes Intervention Study
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard lifestyle guidanceBehavioural
Lifestyle guidance and monotherapy with acarboseDrug
Lifestyle guidance and monotherapy with metforminDrug
Lifestyle guidance and monotherapy with gliclazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FPG >= 140mg/dl and HbA1c >= 7.0%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startApr 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,560 participants
Sponsor and investigators
- Lead sponsor
- Japan Early Diabetes Intervention Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Takeshi Kuzuya, Principal investigator, Jichi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464594
- Sponsor's protocol ID
- JEDIS ver.4.0
- Other IDs
- UMIN000000681
- Acronym
- JEDIS
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2007
- Last updated
- 24 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention
- ClinicalTrials.gov ID
- NCT00464594
- Acronym / sponsor ID
- JEDIS / JEDIS ver.4.0
- Conditions
- Diabetes Mellitus
- Keywords
- Japan Early Diabetes Intervention Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,560 participants
- Lead sponsor
- Japan Early Diabetes Intervention Study GroupUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 23 Apr 2007 (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.
The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).
Detailed description
In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9%
Key exclusion criteria (19 listed)
- Type 1 diabetes mellitus
- Undergoing treatment with steroids
- Secondary diabetes mellitus
- Diabetes mellitus due to suspected gene abnormalities
- BMI >= 35 kg/m2 or BMI < 18.5 kg/m2
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 |
|---|---|---|
| Standard lifestyle guidance | Behavioural | – |
| Lifestyle guidance and monotherapy with acarbose | Drug | – |
| Lifestyle guidance and monotherapy with metformin | Drug | – |
| Lifestyle guidance and monotherapy with gliclazide | Drug | – |
Primary outcome
FPG >= 140mg/dl and HbA1c >= 7.0%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
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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.
Takeshi Kuzuya principal investigator
Jichi Medical 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 Standard lifestyle guidance, Lifestyle guidance and monotherapy with acarbose and Lifestyle guidance and monotherapy with metformin in people with Diabetes Mellitus, run by Japan Early Diabetes Intervention Study Group at 1 site in Japan.
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 1 inclusion and 19 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 24 Apr 2007. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kazuo Ichikawa (81-3-3814-8010, info@jedis2560.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FPG >= 140mg/dl and HbA1c >= 7.0%. 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 24 Apr 2007.