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Surgical Treatment of Non-Obese Type 2 Diabetic Patients With Duodenal Exclusion
This study is ongoing, but not recruiting participants.
Study NCT00566358   Information provided by University of Campinas, Brazil
First Received: November 30, 2007   Last Updated: February 2, 2009   History of Changes

November 30, 2007
February 2, 2009
January 2006
June 2009   (final data collection date for 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00566358 on ClinicalTrials.gov Archive Site
  • Changes in body weight and fat distribution after intervention [ Time Frame: 1 month, 2 months, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Changes in seric free fatty acids and lipoproteins [ Time Frame: one month, 2 months, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Regression of carotid intima-media thickness [ Time Frame: 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
Same as current
 
Surgical Treatment of Non-Obese Type 2 Diabetic Patients With Duodenal Exclusion
Lightening the Hormonal Mechanisms of Surgical Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Surgery

Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.

In order to try this hypothesis, RUBINO and MARESCAUX (2004) studied the gastrojejunal bypass (duodenal exclusion)in an mouse model of diabetes without obesity. In their technique the stomach volume is kept intact, maintaining the caloric ingestion and the weight of the animals. There was a fast improvement of diabetes, independent of diet and weight, without the potential nutritional deprivations commonly seen in the bariatric surgery like iron and vitamin deficiency.

This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery in human non-obese, diabetic volunteers and known insulin secretion capacity, by the method of standardized meal stimulus. It is expected to be secondary to changes in the gastrointestinal hormones that stimulate insulin secretion (incretins).

The knowledge about the clinical outcomes of this technique in humans and the description of the secretion pattern of gastrointestinal hormones after the surgery may contribute to the implementation of this surgery as a new therapeutic option for overweight (non-obese) diabetic patients.

There is large recovery of insulin sensibility after bariatric surgery, as the patients get closer to ideal weight. Diabetes reversion is more frequent after predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Glycemia normalization occurs in an early phase of the postoperative period, even before significant weight loss could explain it. These techniques have in common a bypass of the duodenum and part of the jejunum. Many peptides are released in this segments that regulate pancreatic beta cells (insulin producers) either in physiological state or in diabetes. Anatomical-functional changes in the enteroinsular axis would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.

In order to try this hypothesis, RUBINO and MARESCAUX (2004) studied the gastrojejunal bypass (duodenal exclusion)in Goto-Kakizaki mice (GK), the most used animal model of diabetes without obesity. In their technique the stomach volume is kept intact, maintaining the caloric ingestion and the weight of the animals. There was a fast improvement of diabetes, independent of diet and weight. The authors concluded that this procedure should be applied in humans for reversal of diabetes without the potential nutritional deprivations commonly seen in the bariatric surgery like iron and vitamin deficiency.

The amelioration of diabetes after bariatric surgery is related to the modulation of production of gastrointestinal hormones relevant to the insulin production (incretin effect).

This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery in human non-obese, diabetic volunteers and known insulin secretion capacity, by the method of standardized meal stimulus. It is expected to be secondary to changes in the gastrointestinal hormones that stimulate insulin secretion (incretins).

The knowledge about the clinical outcomes of this technique in humans and the description of the secretion pattern of gastrointestinal hormones after the surgery may contribute to the implementation of this surgery as a new therapeutic option for overweight (non-obese) diabetic patients.

Phase I, Phase II
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Diabetes Mellitus, Type 2
Procedure: Duodenal exclusion surgery
Experimental: Duodenal exclusion
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
12
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00566358
Bruno Geloneze, University of Campinas, Brazil
LIMED0002
University of Campinas, Brazil
Ethicon Endo-Surgery
Principal Investigator: Bruno Geloneze, MD, PhD University of Campinas (UNICAMP)
Principal Investigator: José Carlos Pareja, MD, PhD University of Campinas (UNICAMP)
University of Campinas, Brazil
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP