Type 2 DiabetesNCT00879125
Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia
An observational study of Type 2 Diabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. Read more about this study
- Who is it for?
- Ages 17 to 66 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Nov 2007
- 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 17 to 66 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Type 2 diabetes with a BMI over 35kg/m2
Who may be able to join
- Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. -
- Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia
This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.
Read the detailed description
Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include:
- HbA1c
- Fasting blood glucose
- Fasting Insulin
- Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.
- Conditions
- Type 2 Diabetes
- Keywords
- Gastric by-pass on patients with T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
Measured: one year
Secondary outcomes (1)
Correction of lipid profiles
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startNov 1999
- Primary completionNov 2007
- Study completionNov 2007
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- William O Richards, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879125
- Sponsor's protocol ID
- 080368
- Status last verified
- Sep 2009
- First submitted
- 8 Apr 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia
- ClinicalTrials.gov ID
- NCT00879125
- Acronym / sponsor ID
- 080368
- Conditions
- Type 2 Diabetes
- Keywords
- Gastric by-pass on patients with T2DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 1999
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Apr 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.
This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.
Detailed description
Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include:
- HbA1c
- Fasting blood glucose
- Fasting Insulin
- Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Type 2 diabetes with a BMI over 35kg/m2
Key inclusion criteria (3 listed)
- Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. -
- Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam.
- -
Key exclusion criteria (0 listed)
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
glycemic control
Time frame: one year
1 secondary outcome
Correction of lipid profiles
Time frame: one year
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 14 Sep 2009.
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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.
William O Richards, MD principal investigator
Vanderbilt University Medical Center
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, run by Vanderbilt University 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 0 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 14 Sep 2009. 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.
What does the primary outcome measure?
glycemic control (time frame: one year). 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 14 Sep 2009.