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Diabetes Mellitus, Type 2NCT00965302

Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

A study testing Laparoscopic sleeve gastrectomy and Intensive medical management in people with Diabetes Mellitus, Type 2 and Obesity, run by 59th Medical Wing at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2, Obesity
What is being tested?
Laparoscopic sleeve gastrectomy and Intensive medical management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Aug 2009to Sep 2014
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetes mellitus, Type 2
  • Body Mass Index (BMI) 30-34.9
  • Able to understand and comply with study process

Who cannot join

  • Pregnancy
  • Prior bariatric surgery
  • Diabetes mellitus, Type 1
  • Renal impairment
  • Cirrhosis or portal hypertension
  • Diabetes secondary to a specific condition
Show all 12Show fewer
  • Recent internal malignancy (<5 years)
  • Recent major vascular event
  • Drug or alcohol dependence
  • Uncontrolled psychiatric disease
  • Crippling cardiopulmonary disease
  • Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilford Hall Medical Center

    San Antonio, Texas, 78236

Other trials in United States

About this study

Official title: Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.

Being tested
Laparoscopic sleeve gastrectomy, Intensive medical management
Keywords
Obesity, Diabetes mellitus, Type 2, Sleeve gastrectomy, Metabolic surgery
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 sleeve gastrectomyProcedure or surgery

    Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.

  • Intensive medical managementBehavioural

    Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.

Study groups in NCT00965302
Study groupRoleWhat they receive
Intensive medical management of Type 2 DMActive comparatorIntensive medical management of Type II diabetes will include visits every three months for a year with an endocrinologist, with lifestyle counseling, weight management, regular exercise, and glucose control forming the core of the medical therapy.
Receives: Behavioral: Intensive medical management
Laparoscopic sleeve gastrectomyExperimentalLaparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.
Receives: Procedure: Laparoscopic sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes remission

    Measured: 1 year

Secondary outcomes (4)

  1. Weight loss

    Measured: 1 year

  2. Obstructive sleep apnea remission

    Measured: 1 year

  3. Fasting lipid profile

    Measured: 1 year

  4. c-reactive protein

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2012
  4. Study completionSep 2014

Why it stopped: Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00965302
Sponsor's protocol ID
FWH20090068H
Status last verified
Apr 2023
First submitted
24 Aug 2009
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005.

    PubMed 16670131

  • Kakoulidis TP, Karringer A, Gloaguen T, Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis. 2009 Jul-Aug;5(4):425-8. doi: 10.1016/j.soard.2008.09.009. Epub 2008 Sep 26.

    PubMed 18996758

  • Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.

    PubMed 17356932

  • Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008 Jan 23;299(3):316-23. doi: 10.1001/jama.299.3.316.

    PubMed 18212316

  • Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011.

    PubMed 16925363

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic sleeve gastrectomy and Intensive medical management in people with Diabetes Mellitus, Type 2 and Obesity, run by 59th Medical Wing 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 12 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 25 Apr 2023. 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 was stopped early (reason given: Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.). 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?

Diabetes remission (time frame: 1 year). 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 NCT00965302, which also lists 5 linked publications.

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 Apr 2023.

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