Diabetes Mellitus, Type 2Phase 1/2NCT00566215
Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Associated With Omentectomy: Clinical and Hormonal Study
A Phase 1/2 study testing Duodenal exclusion plus omentectomy and Duodenal exclusion without omentectomy in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- What is being tested?
- Duodenal exclusion plus omentectomy and Duodenal exclusion without omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Jun 2009
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 60 years.
- BMI between 25 and 29,9 kg/m².
- Weight variance less than 5% in the last 3 months.
- Previous diagnosis of diabetes type 2.
- Insulin requirement, alone or along with oral agents
- Capacity to understand the procedures of the study.
- To agree voluntarily to participate of the study, signing an informed consent.
Who cannot join
- Positive Anti-GAD antibodies
- Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- History of hepatic disease like cirrhosis or chronic active hepatitis.
- Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- Hepatic dysfunction: ALT and/or AST 3x above upper normal limit.
- Recent history of neoplasia (< 5 years).
- Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
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
About this study
Official title: Clinical and Hormonal Study of a New Surgical Treatment of Type 2 Diabetes Mellitus: Duodenal Exclusion Associated With Omentectomy
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
Read more
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy, by the method of standardized meal stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
Read the detailed description
Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures, followed by those combining malabsorption and gastric restriction. Changes in the hormonal communication between the digestive system (incretins)and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion: the stomach volume is kept intact, maintaining the caloric ingestion and the weight reduces less than 5%, without the potential nutritional deprivations commonly seen in the bariatric surgery. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered. An standardized mixed meal tolerance test showed favorable changes in the gastrointestinal hormones that stimulate insulin secretion (incretins): increase of GLP-1 and reduction of GIP.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
In fact, surgical removal of visceral fat in rodents improves insulin sensitivity. A pilot study in human, obese volunteers submitted to gastric adjustable band was promising int this aspect.
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy , by the method of standardized meal stimulus and insulin tolerance test, in human non-obese, volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- Being tested
- Duodenal exclusion plus omentectomy, Duodenal exclusion without omentectomy
- Keywords
- diabetes mellitus, type 2, Insulin resistance, Intra-Abdominal Fat, Omentum, duodenal exclusion, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide, insulin, glucagon, ghrelin, adiponectin, Cytokines
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal exclusion plus omentectomyProcedure or surgery
Also called Duodenojejunal exclusion plus omentectomy, Duodenal-jejunal bypass plus omentectomy
Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
Additionally, total omentectomy is performed.
Duodenal exclusion without omentectomyProcedure or surgery
Also called Duodenojejunal exclusion, Duodenal-jejunal bypass
Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Duodenal exclusion plus total omentectomy Receives: Procedure: Duodenal exclusion plus omentectomy |
| 2 | Active comparator | Duodenal exclusion without omentectomy Receives: Procedure: Duodenal exclusion without omentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement or reversal of type 2 diabetes mellitus
Measured: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year
Secondary outcomes (6)
Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test
Measured: 2 months, 6 months and 1 year
Changes in body weight and fat distribution after intervention
Measured: 1 month, 2 months, 3 months, 6 months and 1 year
Changes in seric free fatty acids and lipoproteins
Measured: one month, 2 months, 3 months, 6 months and 1 year
Regression of carotid intima-media thickness
Measured: 1 month, 3 months, 6 months and 1 year
Changes in seric levels of adiponectin and other adipokines.
Measured: 2 months, 6 months and 1 year
Improvement of insulin sensitivity as measured by insulin tolerance test.
Measured: 1 month, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Benefit of duodenal exclusion alone less than expected for treatment of type 2 diabetes; an additional effect of combination with omentectomy not observed
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 Diabetes Mellitus, Type 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- José Carlos Pareja, MD, PhD, Principal investigator, University of Campinas (UNICAMP)Bruno Geloneze, MD, PhD, Principal investigator, University of Campinas (UNICAMP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566215
- Sponsor's protocol ID
- LIMED0003
- Status last verified
- Jul 2010
- First submitted
- 30 Nov 2007
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubino F, Marescaux J. Effect of duodenal-jejunal exclusion in a non-obese animal model of type 2 diabetes: a new perspective for an old disease. Ann Surg. 2004 Jan;239(1):1-11. doi: 10.1097/01.sla.0000102989.54824.fc.
PubMed 14685093Thorne 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 11850750Pitombo 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 17170226Barzilai 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 9892227Gabriely 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 12351432Geloneze B, Geloneze SR, Fiori C, Stabe C, Tambascia MA, Chaim EA, Astiarraga BD, Pareja JC. Surgery for nonobese type 2 diabetic patients: an interventional study with duodenal-jejunal exclusion. Obes Surg. 2009 Aug;19(8):1077-83. doi: 10.1007/s11695-009-9844-4. Epub 2009 May 12.
PubMed 19475464
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Hormonal Study of a New Surgical Treatment of Type 2 Diabetes Mellitus: Duodenal Exclusion Associated With Omentectomy
- ClinicalTrials.gov ID
- NCT00566215
- Acronym / sponsor ID
- LIMED0003
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
- Keywords
- diabetes mellitus, type 2, Insulin resistance, Intra-Abdominal Fat, Omentum, duodenal exclusion, bariatric surgery, Glucagon-Like Peptide 1, Gastric Inhibitory Polypeptide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Benefit of duodenal exclusion alone less than expected for treatment of type 2 diabetes; an additional effect of combination with omentectomy not observed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Dec 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.
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy, by the method of standardized meal stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
Detailed description
Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures, followed by those combining malabsorption and gastric restriction. Changes in the hormonal communication between the digestive system (incretins)and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion: the stomach volume is kept intact, maintaining the caloric ingestion and the weight reduces less than 5%, without the potential nutritional deprivations commonly seen in the bariatric surgery. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered. An standardized mixed meal tolerance test showed favorable changes in the gastrointestinal hormones that stimulate insulin secretion (incretins): increase of GLP-1 and reduction of GIP.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
In fact, surgical removal of visceral fat in rodents improves insulin sensitivity. A pilot study in human, obese volunteers submitted to gastric adjustable band was promising int this aspect.
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy , by the method of standardized meal stimulus and insulin tolerance test, in human non-obese, volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Duodenal exclusion plus omentectomyDuodenal exclusion plus total omentectomy |
| 2 | Active comparator | Procedure: Duodenal exclusion without omentectomyDuodenal exclusion without omentectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 to 60 years.
- BMI between 25 and 29,9 kg/m².
- Weight variance less than 5% in the last 3 months.
- Previous diagnosis of diabetes type 2.
- Insulin requirement, alone or along with oral agents
Key exclusion criteria (7 listed)
- Positive Anti-GAD antibodies
- Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- History of hepatic disease like cirrhosis or chronic active hepatitis.
- Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- Hepatic dysfunction: ALT and/or AST 3x above upper normal limit.
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 |
|---|---|---|
| Duodenal exclusion plus omentectomyAlso: Duodenojejunal exclusion plus omentectomy, Duodenal-jejunal bypass plus omentectomyUnder open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union. Additionally, total omentectomy is performed. | Procedure or surgery | 1 |
| Duodenal exclusion without omentectomyAlso: Duodenojejunal exclusion, Duodenal-jejunal bypassUnder open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create a excluded biliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the gastrojejunal continuity and the anastomosis of the excluded biliopancreatic limb is done 100cm below the jejunal-pyloric union. | Procedure or surgery | 2 |
Primary outcome
Improvement or reversal of type 2 diabetes mellitus
Time frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year
6 secondary outcomes
Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test
Time frame: 2 months, 6 months and 1 year
Changes in body weight and fat distribution after intervention
Time frame: 1 month, 2 months, 3 months, 6 months and 1 year
Changes in seric free fatty acids and lipoproteins
Time frame: one month, 2 months, 3 months, 6 months and 1 year
Regression of carotid intima-media thickness
Time frame: 1 month, 3 months, 6 months and 1 year
Changes in seric levels of adiponectin and other adipokines.
Time frame: 2 months, 6 months and 1 year
Improvement of insulin sensitivity as measured by insulin tolerance test.
Time frame: 1 month, 3 months, 6 months and 1 year
Results and safety
The study was stopped early (reason given: Benefit of duodenal exclusion alone less than expected for treatment of type 2 diabetes; an additional effect of combination with omentectomy not observed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- Background: PubMed 14685093Rubino F, Marescaux J. Effect of duodenal-jejunal exclusion in a non-obese animal model of type 2 diabetes: a new perspective for an old disease. Ann Surg. 2004 Jan;239(1):1-11. doi: 10.1097/01.sla.0000102989.54824.fc.
- 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 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.
- 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.
- Results publication: PubMed 19475464Geloneze B, Geloneze SR, Fiori C, Stabe C, Tambascia MA, Chaim EA, Astiarraga BD, Pareja JC. Surgery for nonobese type 2 diabetic patients: an interventional study with duodenal-jejunal exclusion. Obes Surg. 2009 Aug;19(8):1077-83. doi: 10.1007/s11695-009-9844-4. Epub 2009 May 12.
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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.
José Carlos Pareja, MD, PhD principal investigator
University of Campinas (UNICAMP)
Bruno Geloneze, MD, 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?
A Phase 1/2 study testing Duodenal exclusion plus omentectomy and Duodenal exclusion without omentectomy in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by University of Campinas, Brazil at 1 site in Brazil.
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 7 inclusion and 7 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 23 Jul 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Benefit of duodenal exclusion alone less than expected for treatment of type 2 diabetes; an additional effect of combination with omentectomy not observed). 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?
Improvement or reversal of type 2 diabetes mellitus (time frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, 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 NCT00566215, 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 23 Jul 2010.