Metabolic Effects of Gastrointestinal Surgery in T2DM

NCT ID: NCT01771185

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

Brief Summary

Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Best medical treatment

Metformin 2 g/day; gliclazide 30 mg

Group Type: ACTIVE_COMPARATOR

Best medical treatment (Metformin ; gliclazide)

Intervention Type: DRUG

Metformin 2 g/day; gliclazide 30 mg

Duodenal jejunal bypass plus sleeve gastrectomy

Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure

Group Type: ACTIVE_COMPARATOR

Duodenal jejunal bypass plus sleeve gastrectomy

Intervention Type: PROCEDURE

Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

Interventions

Duodenal jejunal bypass plus sleeve gastrectomy

Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

Intervention Type: PROCEDURE

Best medical treatment (Metformin ; gliclazide)

Metformin 2 g/day; gliclazide 30 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Uncontrolled diabetes ( A1c>8%)
• Less than 10 years of history
• Not taking insulin
• Ages between 20 and 65 years old
• BMI between 26-34

Exclusion Criteria

• previous abdominal surgery
• LADA
• Using insulin

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Cohen

Clinical Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HUUSP001

Identifier Type: -

Identifier Source: org_study_id