Metabolic Effects of Gastrointestinal Surgery in T2DM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Ricardo Cohen, University of Sao Paulo Identifier:
First received: January 14, 2013
Last updated: January 17, 2013
Last verified: January 2013
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

Condition Intervention
Type 2 Diabetes
Procedure: Duodenal jejunal bypass plus sleeve gastrectomy
Drug: Best medical treatment (Metformin ; gliclazide)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Hb A1a [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
    Primary endpoints- glycemic control

Secondary Outcome Measures:
  • Systolic and diastolic blood pressure control [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
  • fasting glycemic control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Lipidic control [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Best medical treatment
Metformin 2 g/day; gliclazide 30 mg
Drug: Best medical treatment (Metformin ; gliclazide)
Metformin 2 g/day; gliclazide 30 mg
Active Comparator: Duodenal jejunal bypass plus sleeve gastrectomy
Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure
Procedure: Duodenal jejunal bypass plus sleeve gastrectomy
Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ricardo Cohen, Clinical Professor of Surgery, University of Sao Paulo Identifier: NCT01771185     History of Changes
Other Study ID Numbers: HUUSP001 
Study First Received: January 14, 2013
Last Updated: January 17, 2013
Health Authority: Brasil: Ethics Committee

Keywords provided by University of Sao Paulo:
metabolic surgery
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 09, 2016