Diabetes Mellitus, Type 2Phase 4NCT00543621
An Intervention Program to Control Diabetes
A Phase 4 study testing daily enteral nutritional product and/or behavioral changes in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 1 site in China.
Trial summary
Study to evaluate the effectiveness of a structured intervention to improve diabetes control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- daily enteral nutritional product and/or behavioral changes
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2005to not given
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- informed consent
- 18-70 adults
- Type 2 Diabetes
- Males and non-pregnant females
Who cannot join
- Use of exogenous insulin for glucose control
- Use of medications or supplements for weight loss
- Advanced diabetes complications
- Recent history of cardiovascular event
Trial locations and contacts
1 site in 1 country.
About this study
Study to evaluate the effectiveness of a structured intervention to improve diabetes control.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- daily enteral nutritional product and/or behavioral changes
- 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.
daily enteral nutritional product and/or behavioral changesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, Fasting blood glucose,blood pressure, weight loss
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jianqin Sun, MD, MPH, Principal investigator, Clinical Nutrition Center, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543621
- Sponsor's protocol ID
- Welltech Study
- Status last verified
- Oct 2007
- First submitted
- 12 Oct 2007
- Last updated
- 15 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Program to Control Diabetes
- ClinicalTrials.gov ID
- NCT00543621
- Acronym / sponsor ID
- Welltech Study
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2005
- First posted
- 15 Oct 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.
Study to evaluate the effectiveness of a structured intervention to improve diabetes control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- 18-70 adults
- Type 2 Diabetes
- Males and non-pregnant females
Key exclusion criteria (4 listed)
- Use of exogenous insulin for glucose control
- Use of medications or supplements for weight loss
- Advanced diabetes complications
- Recent history of cardiovascular event
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 |
|---|---|---|
| daily enteral nutritional product and/or behavioral changes | Other | – |
Primary outcome
HbA1c, Fasting blood glucose,blood pressure, weight loss
Time frame: 24 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 15 Oct 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.
Jianqin Sun, MD, MPH principal investigator
Clinical Nutrition Center, Huadong 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 daily enteral nutritional product and/or behavioral changes in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 1 site in China.
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 4 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 15 Oct 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 China. 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?
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?
HbA1c, Fasting blood glucose,blood pressure, weight loss (time frame: 24 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 15 Oct 2007; AzTrials last refreshed its copy on 29 Oct 2026.