Type 2 DiabetesBOSNCT00592735
Effects of Medical and Surgical Weight Loss on Metabolism
An observational study of Type 2 Diabetes and Obesity, run by Garvan Institute of Medical Research at 1 site in Australia.
Trial summary
This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- laparoscopic gastric banding
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- May 2007to May 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: morbidly obese subjects with type 2 diabetes or metabolic syndrome
Who may be able to join
- morbidly obese subjects with type 2 diabetes or metabolic syndrome
- age <70
Who cannot join
- contra-indications to bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Adipocyte-derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss
This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- laparoscopic gastric banding
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric bandingProcedure or surgery
standard surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: laparoscopic gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Katherine Samaras, Garvan Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592735
- Sponsor's protocol ID
- SVH H06/151
- Other IDs
- SVH H06/151
- Acronym
- BOS
- Status last verified
- Jun 2016
- First submitted
- 1 Jan 2008
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adipocyte-derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss
- ClinicalTrials.gov ID
- NCT00592735
- Acronym / sponsor ID
- BOS / SVH H06/151
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Jan 2008 (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.
This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: laparoscopic gastric banding |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- morbidly obese subjects with type 2 diabetes or metabolic syndrome
Key inclusion criteria (2 listed)
- morbidly obese subjects with type 2 diabetes or metabolic syndrome
- age <70
Key exclusion criteria (1 listed)
- contra-indications to bariatric surgery
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 |
|---|---|---|
| laparoscopic gastric bandingstandard surgical procedure | Procedure or surgery | 1 |
Primary outcome
weight loss
Time frame: 6 months
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 7 Jun 2016.
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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?
An observational study of Type 2 Diabetes and Obesity, run by Garvan Institute of Medical Research at 1 site in Australia.
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 2 inclusion and 1 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 7 Jun 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 Australia. 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?
weight loss (time frame: 6 months). 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 7 Jun 2016.