New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I - Tabular View

Tracking Information

First Received Date ^ICMJE

November 30, 2007

Last Updated Date

February 11, 2009

Start Date ^ICMJE

August 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00566189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improvement of insulin sensitivity as measured by insulin tolerance test [ Time Frame: 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines [ 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 ]
Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

Official Title ^ICMJE

New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2

Brief Summary

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Detailed Description

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.

This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2
Insulin Resistance
Obesity

Intervention ^ICMJE

Procedure: Roux-en-Y Bypass Gastroplasty

Study Arms / Comparison Groups

Experimental: Roux-en-Y bypass gastroplasty

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Obesity grade I (BMI 30-34,9)
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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bruno Geloneze, MD, PhD

+55-19-3521-8589

limedunicamp@gmail.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00566189

Responsible Party

Bruno Geloneze, University of Campinas, Brazil

Study ID Numbers ^ICMJE

LIMED0004

Study Sponsor ^ICMJE

University of Campinas, Brazil

Collaborators ^ICMJE

Ethicon Endo-Surgery

Investigators ^ICMJE

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

Information Provided By

University of Campinas, Brazil

Verification Date

February 2009

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