Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Associated With Omentectomy: Clinical and Hormonal Study

July 22, 2010 updated by: University of Campinas, Brazil

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 We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.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 .

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil
        • LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Duodenal exclusion plus total omentectomy
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.

Other Names:
  • Duodenojejunal exclusion plus omentectomy
  • Duodenal-jejunal bypass plus omentectomy
Active Comparator: 2
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.
Other Names:
  • Duodenojejunal exclusion
  • Duodenal-jejunal bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
1 month, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: José Carlos Pareja, MD, PhD, University of Campinas (UNICAMP)
  • Principal Investigator: Bruno Geloneze, MD, PhD, University of Campinas (UNICAMP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIMED0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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