Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2Phase 2OMTNCT00565799
A Pilot Study of Metabolic Effects of Omentectomy
A Phase 2 study testing Omentectomy in people with Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 and Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, run by NYU Langone Health at 1 site in United States.
Trial summary
PROTOCOL SUMMARY Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, Age 18-64 Years
- What is being tested?
- Omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2010
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Who cannot join
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Metabolic Effects of Omentectomy in Obese Patients With Type 2 Diabetes Mellitus Treated With Laparoscopic Adjustable Gastric Banding (LAGB)
PROTOCOL SUMMARY
Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.
Read more
Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
We hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies.
Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at New York University Medical Center will be invited to participate in this study. Subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).
Read the detailed description
Inclusion Criteria:
- Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Exclusion Criteria:
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with routine pre-op visit) -4 OGTT \& randomization -2 Preliminary genetic testing for the future study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4 OGTT 6
STUDY PLAN
Study has approved by IRB, NYU School of Medicine Committee, GCRC, and Bellevue Hospital.
Study initiation date: November 01, 2007
Enrollment period: Nov. 2007 to Nov. 2008
Study period: Nov. 2007 to Jan 2008
- Conditions
- Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, Age 18-64 Years
- Being tested
- Omentectomy, No intervention
- Keywords
- DM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmentectomyProcedure or surgery
Removing the omentum
No interventionOther
Only LAGB without Omentectomy
| Study group | Role | What they receive |
|---|---|---|
| 1. Omentectomy | Active comparator | LAGB \& Omentectomy Receives: Procedure: Omentectomy |
| 2 No Omentectomy | Placebo comparator | LAGB Only Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Measured: 6 week post op
Secondary outcomes (1)
Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
Measured: 6 week post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Conflicting interim data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Christine Ren, M.D., Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565799
- Sponsor's protocol ID
- 07-178
- Acronym
- OMT
- Status last verified
- Nov 2015
- First submitted
- 28 Nov 2007
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Metabolic Effects of Omentectomy in Obese Patients With Type 2 Diabetes Mellitus Treated With Laparoscopic Adjustable Gastric Banding (LAGB)
- ClinicalTrials.gov ID
- NCT00565799
- Acronym / sponsor ID
- OMT / 07-178
- Conditions
- Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, Age 18-64 Years
- Keywords
- DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Conflicting interim data
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Nov 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Nov 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.
PROTOCOL SUMMARY
Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.
Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
We hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies.
Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at New York University Medical Center will be invited to participate in this study. Subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).
Detailed description
Inclusion Criteria:
- Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Exclusion Criteria:
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with routine pre-op visit) -4 OGTT \& randomization -2 Preliminary genetic testing for the future study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4 OGTT 6
STUDY PLAN
Study has approved by IRB, NYU School of Medicine Committee, GCRC, and Bellevue Hospital.
Study initiation date: November 01, 2007
Enrollment period: Nov. 2007 to Nov. 2008
Study period: Nov. 2007 to Jan 2008
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Omentectomy | Active comparator | Procedure: OmentectomyLAGB \& Omentectomy |
| 2 No Omentectomy | Placebo comparator | Other: No interventionLAGB Only |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Key exclusion criteria (3 listed)
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
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 |
|---|---|---|
| OmentectomyRemoving the omentum | Procedure or surgery | 1. Omentectomy |
| No interventionOnly LAGB without Omentectomy | Other | 2 No Omentectomy |
Primary outcome
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
Time frame: 6 week post op
1 secondary outcome
Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
Time frame: 6 week post op
Results and safety
The study was stopped early (reason given: Conflicting interim data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Related InfoLink provided by the sponsor.
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.
Christine Ren, M.D. principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omentectomy in people with Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 and Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, run by NYU Langone Health 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Nov 2015. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Conflicting interim data). Results are not available in the source record.
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?
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation (time frame: 6 week post op). 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 20 Nov 2015.