DiabetesMAXWELNCT00816608
The Effect of Maximum Body Weight in Lifetime on the Development of Type 2 Diabetes
An observational study of Diabetes and Prediabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes, Prediabetes
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2006to Sep 2013
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean with type 2 diabetes Korean with confirmed IFG or IGT Korean with NGT
Who may be able to join
- Korean with type 2 diabetes
- Korean with confirmed IFG or IGT
- Korean with NGT
Who cannot join
- Malignancy except thyroid cancer
- Active tuberculosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, 463-707
About this study
Official title: Study of MAXimum Weight in Lifetime on Glucose Homeostasis (MAXWEL)
Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes.
Read the detailed description
Obesity is well recognized risk factor for type 2 diabetes. Recent studies reported that weight change, especially severe weight gain was associated with an increased risk of type 2 diabetes. The aim of this study is to investigate whether the maximum body weight of lifetime is associated with the early onset of type 2 diabetes or an increased risk of type 2 diabetes in Korean.
- Conditions
- Diabetes, Prediabetes
- Keywords
- diabetes, prediabetes, impaired fasting glucose (IFG), impaired glucose tolerance (IGT), body weight
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Glucose Intolerance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of diabetes
Measured: Five years
Secondary outcomes (1)
DM complication
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startAug 2006
- Primary completionDec 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816608
- Sponsor's protocol ID
- MAXWEL 09
- Acronym
- MAXWEL
- Status last verified
- Oct 2013
- First submitted
- 31 Dec 2008
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of MAXimum Weight in Lifetime on Glucose Homeostasis (MAXWEL)
- ClinicalTrials.gov ID
- NCT00816608
- Acronym / sponsor ID
- MAXWEL / MAXWEL 09
- Conditions
- Diabetes, Prediabetes
- Keywords
- diabetes, prediabetes, impaired fasting glucose (IFG), impaired glucose tolerance (IGT), body weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Jan 2009 (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.
Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes.
Detailed description
Obesity is well recognized risk factor for type 2 diabetes. Recent studies reported that weight change, especially severe weight gain was associated with an increased risk of type 2 diabetes. The aim of this study is to investigate whether the maximum body weight of lifetime is associated with the early onset of type 2 diabetes or an increased risk of type 2 diabetes in Korean.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean with type 2 diabetes Korean with confirmed IFG or IGT Korean with NGT
Key inclusion criteria (3 listed)
- Korean with type 2 diabetes
- Korean with confirmed IFG or IGT
- Korean with NGT
Key exclusion criteria (2 listed)
- Malignancy except thyroid cancer
- Active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The development of diabetes
Time frame: Five years
1 secondary outcome
DM complication
Time frame: 5 years
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 25 Oct 2013.
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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.
Soo Lim principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Prediabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 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 25 Oct 2013. 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 South Korea. 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 development of diabetes (time frame: Five years). 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 25 Oct 2013.