This trial is active, not recruiting.

Condition type 2 diabetes
Treatments duodenal jejunal bypass plus sleeve gastrectomy, best medical treatment (metformin ; gliclazide)
Sponsor University of Sao Paulo
Start date October 2012
End date October 2013
Trial size 24 participants
Trial identifier NCT01771185, HUUSP001


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Metformin 2 g/day; gliclazide 30 mg
best medical treatment (metformin ; gliclazide)
Metformin 2 g/day; gliclazide 30 mg
(Active Comparator)
Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure
duodenal jejunal bypass plus sleeve gastrectomy
Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

Primary Outcomes

Hb A1a
time frame: 24 mo

Secondary Outcomes

Systolic and diastolic blood pressure control
time frame: 24 mo
fasting glycemic control
time frame: 24 months
Lipidic control
time frame: 24 months

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

Official title Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo.