Metabolic Effects of Gastrointestinal Surgery in T2DM

Type 2 Diabetes Clinical Trial

Official title:

Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01771185
• Other study ID #: HUUSP001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2013
• Last updated: January 17, 2013
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb A1a	Primary endpoints- glycemic control	24 mo	No
Secondary	Systolic and diastolic blood pressure control		24 mo	No
Secondary	fasting glycemic control		24 months	No
Secondary	Lipidic control		24 months	No