Glucose IntoleranceNCT00006162
Lifestyle Interventions to Reduce Diabetes Risk
A study testing exercise and diet in people with Glucose Intolerance and Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic white population. This appears to be due to the effects of ''westernization'' to bring out metabolic changes that lead to diabetes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glucose Intolerance, Diabetes Mellitus, Type 2
- What is being tested?
- exercise and diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1994to Apr 1999
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese American
- Confirmed impaired glucose tolerance
- Able to fill out questionnaires
Who cannot join
- Significant exercise-restricting disease
- Poorly controlled hypertension
- Psychiatric disease or dementia
- Already on unusually restrictive diet
- Use of hypolipidemic drugs
- Use of tobacco
Show all 9Show fewer
- Abnormal blood screening tests
- ECG evidence of ischemic heart disease at rest
- Abnormal maximal Bruce treadmill test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Reduce Diabetic Risk in Japanese Americans
Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic white population. This appears to be due to the effects of ''westernization'' to bring out metabolic changes that lead to diabetes. This study will look at whether increased physical activity and dietary changes will reduce or prevent the metabolic changes that lead to type 2 diabetes in Japanese Americans who have impaired glucose tolerance, a condition intermediate between normal glucose tolerance and diabetes.
- Conditions
- Glucose Intolerance, Diabetes Mellitus, Type 2
- Being tested
- exercise and diet
- Keywords
- low fat diet, aerobic exercise, impaired glucose tolerance, Japanese Americans, metabolic risk factors
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and dietBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startOct 1994
- Study completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006162
- Sponsor's protocol ID
- fujimotow (completed)
- Other IDs
- 1R01DK048152
- Status last verified
- Mar 2010
- First submitted
- 8 Aug 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Diabetic Risk in Japanese Americans
- ClinicalTrials.gov ID
- NCT00006162
- Acronym / sponsor ID
- fujimotow (completed)
- Conditions
- Glucose Intolerance, Diabetes Mellitus, Type 2
- Keywords
- low fat diet, aerobic exercise, impaired glucose tolerance, Japanese Americans, metabolic risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 1994
- Study completion
- Apr 1999
- First posted
- 9 Aug 2000 (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.
Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic white population. This appears to be due to the effects of ''westernization'' to bring out metabolic changes that lead to diabetes. This study will look at whether increased physical activity and dietary changes will reduce or prevent the metabolic changes that lead to type 2 diabetes in Japanese Americans who have impaired glucose tolerance, a condition intermediate between normal glucose tolerance and diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese American
- Confirmed impaired glucose tolerance
- Able to fill out questionnaires
Key exclusion criteria (9 listed)
- Significant exercise-restricting disease
- Poorly controlled hypertension
- Psychiatric disease or dementia
- Already on unusually restrictive diet
- Use of hypolipidemic drugs
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 |
|---|---|---|
| exercise and diet | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Mar 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and diet in people with Glucose Intolerance and Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 3 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 2 Mar 2010. 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 United States. 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.
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 2 Mar 2010.