A Phase 1/2 interventional study of Duodenal exclusion plus omentectomy and Duodenal exclusion without omentectomy in Diabetes Mellitus, Type 2, Insulin Resistance and Obesity, sponsored by University of Campinas, Brazil. Terminated at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-07-23.
Sponsored by University of Campinas, Brazil · Phase 1/2, Interventional, and Treatment
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 We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 6 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Duodenal exclusion plus total omentectomy
Procedure: Duodenal exclusion plus omentectomy
Duodenal exclusion without omentectomy
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. Additionally, total omentectomy is performed.
Also known as: 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.
Also known as: Duodenojejunal exclusion, Duodenal-jejunal bypass
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
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
This study is terminated, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil →