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Sponsored by: |
University of Campinas, Brazil |
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Information provided by: | University of Campinas, Brazil |
ClinicalTrials.gov Identifier: | NCT00566215 |
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 We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 Insulin Resistance Obesity |
Procedure: Duodenal exclusion plus omentectomy Procedure: Duodenal exclusion without omentectomy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical and Hormonal Study of a New Surgical Treatment of Type 2 Diabetes Mellitus: Duodenal Exclusion Associated With Omentectomy |
Estimated Enrollment: | 12 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Duodenal exclusion plus total omentectomy
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Procedure: Duodenal exclusion 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. |
2: Active Comparator
Duodenal exclusion without omentectomy
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Procedure: Duodenal exclusion without 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.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bruno Geloneze, MD, PhD | +55-19-3521-8589 | limedunicamp@gmail.com |
Brazil, SP | |
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) | Recruiting |
Campinas, SP, Brazil | |
Contact: Brenno D Astiarraga, Biol. +55-19-3521-8589 limedunicamp@gmail.com | |
Principal Investigator: Bruno Geloneze, MD, PhD | |
Principal Investigator: José Carlos Pareja, MD, PhD | |
Sub-Investigator: Sylka R Geloneze, MD | |
Sub-Investigator: Marcelo MO Lima, MD | |
Sub-Investigator: Brenno D Astiarraga, Biol. | |
Sub-Investigator: Carla Fiori, Nurse | |
Sub-Investigator: Elinton Chaim, MD, PhD |
Principal Investigator: | José Carlos Pareja, MD, PhD | University of Campinas (UNICAMP) |
Principal Investigator: | Bruno Geloneze, MD, PhD | University of Campinas (UNICAMP) |
Responsible Party: | University of Campinas, Brazil ( Bruno Geloneze ) |
Study ID Numbers: | LIMED0003 |
Study First Received: | November 30, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00566215 |
Health Authority: | Brazil: National Committee of Ethics in Research |
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 |
Obesity Gastric Inhibitory Polypeptide Metabolic Diseases Glucagon Diabetes Mellitus Endocrine System Diseases Overweight Insulin Glucagon-Like Peptide 1 Body Weight |
Hyperinsulinism Signs and Symptoms Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders |
Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists |
Incretins Hormones Pharmacologic Actions |