Insulin ResistancePhase 2/3NCT00545805

Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity

A Phase 2/3 study testing Roux-en-Y Gastric Bypass plus total omentectomy and Roux-en-Y Gastric Bypass in people with Insulin Resistance and Obesity, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Insulin Resistance, Obesity, Metabolic Syndrome X
What is being tested?: Roux-en-Y Gastric Bypass plus total omentectomy and Roux-en-Y Gastric Bypass
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteBrazil
Study dates: Oct 2005to Jun 2009
Phase: Phase 2/3
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 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Age between 21 and 50 years.
Female sex.
BMI between 40 and 50kg/m2.
Metabolic syndrome (NCEP/ATP III criteria).

Who cannot join

Weight variation >5% within 3 months prior to preoperative tests.
Use of antidiabetic medications within 3 months prior to preoperative tests.
HbA1c >8%.
Use of systemic corticosteroids for longer than 1 week within 3 months prior to preoperative tests.
Hepatic cirrhosis, renal failure or any clinical condition (other than obesity) recognized as impairing insulin sensitivity.
Present Smoking.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, São Paulo

Other trials in Brazil

About this study

Official title: Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery

The intraabdominal fat is associated with insulin resistance, a condition that is in the basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear whether it is the origin of it or a surrogate marker only. We intend to compare the effects of bariatric surgery with versus without omentectomy in morbidly obese people intended to go through bariatric surgery, accessing insulin sensitivity by metabolic tests.

If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy) might lead to improvement of insulin action, as seen in animal studies and in one study with morbidly obese human volunteers.

Read the detailed description

In order to verify a potential additional benefit of omentectomy combined to Roux-en-Y silastic ring gastric bypass, insulin sensitivity will be studied by the gold-standard test, euglycemic-hyperinsulinemic clamp, since early postoperative follow-up (before significant weight variation), compared to a control group of bariatric surgery (same technique) alone. The variables will be analyzed in the post surgical evolution for correlation to metabolic changes: adiposity-related hormones and cytokines; lipid profile and other cardiovascular risk factors; molecular expression of biopsied subcutaneous adipocytes in vitro; anthropometrics; ultrasonography of abdominal subcutaneous and intra-abdominal fat depots and carotid intima-media thickness (preclinical atherosclerosis evaluation).

Conditions: Insulin Resistance, Obesity, Metabolic Syndrome X
Being tested: Roux-en-Y Gastric Bypass plus total omentectomy, Roux-en-Y Gastric Bypass
Keywords: Insulin resistance, Metabolic syndrome X, Obesity, Intra-Abdominal Fat, Omentum, Bariatric surgery, Glucose Clamp Technique, Intravenous Glucose Tolerance Test, Adiponectin, Cytokines
Medical subject headings: Insulin Resistance, Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roux-en-Y Gastric Bypass plus total omentectomyProcedure or surgery
Roux-en-Y Gastric Bypass plus total omentectomy
Roux-en-Y Gastric BypassProcedure or surgery
Roux-en-Y Gastric Bypass without omentectomy

Study groups in NCT00545805
Study group	Role	What they receive
OM group	Experimental	Not described Receives: Procedure: Roux-en-Y Gastric Bypass plus total omentectomy
CT group	Active comparator	Control group Receives: Procedure: Roux-en-Y Gastric Bypass

What is being measured

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

Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
Measured: one month, six months and one year.

Secondary outcomes (4)

increase of insulin secretion as measured by intravenous glucose tolerance test
Measured: one month, six months, one year
regression of carotid intima-media thickness
Measured: one month, six months, one year
Improvement of the insulin cell signalling in the subcutaneous adipose tissue.
Measured: one month, six months
increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance
Measured: one month, six months, one year

Timeline

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

Oct 2005Jun 2009

First posted17 Oct 2007 (estimated)
Study startOct 2005
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Insulin ResistanceStudies 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: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00545805
Sponsor's protocol ID: LIMED0001
Other IDs: FAPESP 05/58627-2
Status last verified: Feb 2013
First submitted: 16 Oct 2007
Last updated: 20 Feb 2013
Results posted: No
Data monitoring committee: No

Publications

Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
PubMed 11850750
Barzilai N, She L, Liu BQ, Vuguin P, Cohen P, Wang J, Rossetti L. Surgical removal of visceral fat reverses hepatic insulin resistance. Diabetes. 1999 Jan;48(1):94-8. doi: 10.2337/diabetes.48.1.94.
PubMed 9892227
Gabriely I, Ma XH, Yang XM, Atzmon G, Rajala MW, Berg AH, Scherer P, Rossetti L, Barzilai N. Removal of visceral fat prevents insulin resistance and glucose intolerance of aging: an adipokine-mediated process? Diabetes. 2002 Oct;51(10):2951-8. doi: 10.2337/diabetes.51.10.2951.
PubMed 12351432
Pitombo C, Araujo EP, De Souza CT, Pareja JC, Geloneze B, Velloso LA. Amelioration of diet-induced diabetes mellitus by removal of visceral fat. J Endocrinol. 2006 Dec;191(3):699-706. doi: 10.1677/joe.1.07069.
PubMed 17170226
Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Geloneze B. Acute effect of roux-en-y gastric bypass on whole-body insulin sensitivity: a study with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Aug;95(8):3871-5. doi: 10.1210/jc.2010-0085. Epub 2010 May 19.
PubMed 20484482
Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.
PubMed 23404948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery
ClinicalTrials.gov ID: NCT00545805
Acronym / sponsor ID: LIMED0001
Conditions: Insulin Resistance, Obesity, Metabolic Syndrome X
Keywords: Insulin resistance, Metabolic syndrome X, Obesity, Intra-Abdominal Fat, Omentum, Bariatric surgery, Glucose Clamp Technique, Intravenous Glucose Tolerance Test
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Campinas, BrazilUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Study start: Oct 2005
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 17 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
OM group	Experimental	Procedure: Roux-en-Y Gastric Bypass plus total omentectomy
CT group	Active comparator	Procedure: Roux-en-Y Gastric BypassControl group

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age between 21 and 50 years.
Female sex.
BMI between 40 and 50kg/m2.
Metabolic syndrome (NCEP/ATP III criteria).

Key exclusion criteria (6 listed)

Weight variation >5% within 3 months prior to preoperative tests.
Use of antidiabetic medications within 3 months prior to preoperative tests.
HbA1c >8%.
Use of systemic corticosteroids for longer than 1 week within 3 months prior to preoperative tests.
Hepatic cirrhosis, renal failure or any clinical condition (other than obesity) recognized as impairing insulin sensitivity.

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
Roux-en-Y Gastric Bypass plus total omentectomyRoux-en-Y Gastric Bypass plus total omentectomy	Procedure or surgery	OM group
Roux-en-Y Gastric BypassRoux-en-Y Gastric Bypass without omentectomy	Procedure or surgery	CT group

Primary outcome

Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
Time frame: one month, six months and one year.

4 secondary outcomes

increase of insulin secretion as measured by intravenous glucose tolerance test
Time frame: one month, six months, one year
regression of carotid intima-media thickness
Time frame: one month, six months, one year
Improvement of the insulin cell signalling in the subcutaneous adipose tissue.
Time frame: one month, six months
increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance
Time frame: one month, six months, 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 20 Feb 2013.
Background: PubMed 11850750Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
Background: PubMed 9892227Barzilai N, She L, Liu BQ, Vuguin P, Cohen P, Wang J, Rossetti L. Surgical removal of visceral fat reverses hepatic insulin resistance. Diabetes. 1999 Jan;48(1):94-8. doi: 10.2337/diabetes.48.1.94.
Background: PubMed 12351432Gabriely I, Ma XH, Yang XM, Atzmon G, Rajala MW, Berg AH, Scherer P, Rossetti L, Barzilai N. Removal of visceral fat prevents insulin resistance and glucose intolerance of aging: an adipokine-mediated process? Diabetes. 2002 Oct;51(10):2951-8. doi: 10.2337/diabetes.51.10.2951.
Background: PubMed 17170226Pitombo C, Araujo EP, De Souza CT, Pareja JC, Geloneze B, Velloso LA. Amelioration of diet-induced diabetes mellitus by removal of visceral fat. J Endocrinol. 2006 Dec;191(3):699-706. doi: 10.1677/joe.1.07069.
Results publication: PubMed 20484482Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Geloneze B. Acute effect of roux-en-y gastric bypass on whole-body insulin sensitivity: a study with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Aug;95(8):3871-5. doi: 10.1210/jc.2010-0085. Epub 2010 May 19.
Results publication: PubMed 23404948Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.

Related trials for Insulin Resistance

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
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Recruiting
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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.

Marcelo MO Lima, MD principal investigator

University of Campinas (UNICAMP)

Bruno Geloneze, PhD principal investigator

University of Campinas (UNICAMP)

José Carlos Pareja, PhD principal investigator

University of Campinas (UNICAMP)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 20 Feb 2013. 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 Brazil. 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.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 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?

Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp. (time frame: one month, six months and one 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 NCT00545805, which also lists 6 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 20 Feb 2013.