ObesityNCT00790309
Early Diabetes Resolution After Weight Loss Surgery
An observational study of Obesity and Diabetes, run by Vanderbilt University Medical Center.
Trial summary
The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Weight loss surgery and Laparoscopic abdominal surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study.
Who may be able to join
- BMI of 30 kg/m2 or higher
- Ages 18-65
- History of impaired glucose tolerance or T2DM
- BMI of 30 kg/m2 or lower
- Ages 18-65
Who cannot join
- Development of an intercurrent infection
- Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
- Current use of thiazolidinediones
- Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)
- Any condition felt by the PI or co-investigators to interfere with ability to complete the study
About this study
Official title: Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery
The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.
- Being tested
- Weight loss surgery, Laparoscopic abdominal surgeries
- Keywords
- Obesity, Diabetes, Bariatric surgery
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss surgeryProcedure or surgery
Weight loss surgery
Laparoscopic abdominal surgeriesProcedure or surgery
laparoscopic abdominal surgeries
| Study group | Role | What they receive |
|---|---|---|
| Weight loss surgery | This group will be comprised of people having weight loss surgery: Roux-en Y gastric bypass, vertical sleeve gastrectomy, or adjustable gastric banding Receives: Procedure: Weight loss surgery | |
| Abdominal surgery | This group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy. Receives: Procedure: Laparoscopic abdominal surgeries | |
| Lean | This group will be comprised of normal weight healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery
Measured: 10 days post-op
Secondary outcomes (1)
Determine changes in inflammatory markers after weight loss surgery
Measured: 10 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University Medical Center
- Investigators
- Naji Abumrad, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790309
- Sponsor's protocol ID
- NNA-Early DM Resolution
- Status last verified
- Apr 2017
- First submitted
- 11 Nov 2008
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
PubMed 26599819
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery
- ClinicalTrials.gov ID
- NCT00790309
- Acronym / sponsor ID
- NNA-Early DM Resolution
- Keywords
- Obesity, Diabetes, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Nov 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.
The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight loss surgery | – | Procedure: Weight loss surgeryThis group will be comprised of people having weight loss surgery: Roux-en Y gastric bypass, vertical sleeve gastrectomy, or adjustable gastric banding |
| Abdominal surgery | – | Procedure: Laparoscopic abdominal surgeriesThis group will be comprised of people having abdominal surgeries such as nissen fundoplication or cholecystectomy. |
| Lean | – | –This group will be comprised of normal weight healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for weight loss surgery or other abdominal surgeries will be considered for the study.
Key inclusion criteria (5 listed)
- BMI of 30 kg/m2 or higher
- Ages 18-65
- History of impaired glucose tolerance or T2DM
- BMI of 30 kg/m2 or lower
- Ages 18-65
Key exclusion criteria (5 listed)
- Development of an intercurrent infection
- Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
- Current use of thiazolidinediones
- Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)
- Any condition felt by the PI or co-investigators to interfere with ability to complete the study
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 |
|---|---|---|
| Weight loss surgeryWeight loss surgery | Procedure or surgery | Weight loss surgery |
| Laparoscopic abdominal surgerieslaparoscopic abdominal surgeries | Procedure or surgery | Abdominal surgery |
Primary outcome
Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery
Time frame: 10 days post-op
1 secondary outcome
Determine changes in inflammatory markers after weight loss surgery
Time frame: 10 days post-op
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 21 Apr 2017.
- Derived from this study: PubMed 26599819Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
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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.
Naji Abumrad, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by Vanderbilt University Medical Center.
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 5 inclusion and 5 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery (time frame: 10 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790309, which also lists 1 linked publication.
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 21 Apr 2017.