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Metabolic Effects of Gastrointestinal Surgery in T2DM

NCT01771185 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-01-18

No results posted yet for this study

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

Interventions

PROCEDURE

Duodenal jejunal bypass plus sleeve gastrectomy

Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

DRUG

Best medical treatment (Metformin ; gliclazide)

Metformin 2 g/day; gliclazide 30 mg

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771185 on ClinicalTrials.gov