Surgical Treatment of Non-obese Type 2 Diabetic Patients With Duodenal Exclusion

NCT00566358 | Completed Phase 1

• 1 other identifier: LIMED0002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, type 2; duodenal exclusion; bariatric surgery; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; insulin; glucagon; ghrelin

Outcome Measures

Primary Outcomes (2)

• Improvement or reversal of type 2 diabetes mellitus

  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

  2 months, 6 months and 1 year

Secondary Outcomes (3)

• Changes in body weight and fat distribution after intervention

  1 month, 2 months, 3 months, 6 months and 1 year

• Changes in seric free fatty acids and lipoproteins

  one month, 2 months, 3 months, 6 months and 1 year

• Regression of carotid intima-media thickness

  1 month, 3 months, 6 months and 1 year

Study Arms (1)

1

EXPERIMENTAL

Duodenal exclusion

Procedure: Duodenal exclusion surgery

Interventions

Duodenal exclusion surgery PROCEDURE

Under open laparotomy, a duodenum section 2cm below the pylorus and a jejunum section below Treitz's Angle to create an 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: Duodeno-jejunal exclusion, Duodenal-jejunal bypass

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (1)

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

Campinas, São Paulo, Brazil

Location

Related Publications (2)

• 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.

  PMID: 14685093 BACKGROUND

• Geloneze 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.

  PMID: 19475464 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Bruno Geloneze, MD, PhD

  University of Campinas (UNICAMP)

  PRINCIPAL INVESTIGATOR

• José Carlos Pareja, MD, PhD

  University of Campinas (UNICAMP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

BR (1)