Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

Completed

• Conditions: Diabetes; Bariatric Surgery; Obesity
• Interventions: Other: No intervention

• Registration Number: NCT00834938
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. There appears to be a variable response to surgery depending on surgical and patient factors. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Detailed Description

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.

To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-07
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Completion: 2010-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Capacity to understand the procedures of the study.
• To agree voluntarily to participate of the study, signing an informed consent.
• Weight variance less than 5% in the last 3 months.
• Operative group with at least 2 year follow-up.

Exclusion Criteria

• 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 for more than consecutive 14 days in the last three months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	No intervention	Patients with DM2 undergoing RYGB without remission of DM2
1	No intervention	Patients with DM2 undergoing RYGB with remission of DM2

Primary Outcome Measures

Name	Time	Method
Describe the endogenous response of incretins, orexins and anorexins to a mixed meal test in obese patients with DM2, in patients with DM2 undergoing RYGB with remission of DM2 and in patients without remission.	2 years after RYGB

Trial Locations

Locations (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP); 🇧🇷 Campinas, São Paulo, Brazil