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Metabolic Effects of Gastrointestinal Surgery in T2DM

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ClinicalTrials.gov Identifier: NCT01771185
Recruitment Status : Unknown
Verified January 2013 by Ricardo Cohen, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Hb A1a [ Time Frame: 24 mo ]
    Primary endpoints- glycemic control


Secondary Outcome Measures :
  1. Systolic and diastolic blood pressure control [ Time Frame: 24 mo ]
  2. fasting glycemic control [ Time Frame: 24 months ]
  3. Lipidic control [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
More Information

Responsible Party: Ricardo Cohen, Clinical Professor of Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01771185     History of Changes
Other Study ID Numbers: HUUSP001
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013

Keywords provided by Ricardo Cohen, University of Sao Paulo:
Diabetes
metabolic surgery
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs