Metabolic Effects of Gastrointestinal Surgery in T2DM

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01771185

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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	Phase
Type 2 Diabetes	Procedure: Duodenal jejunal bypass plus sleeve gastrectomy Drug: Best medical treatment (Metformin ; gliclazide)	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

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

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

Hb A1a [24 mo]
Primary endpoints- glycemic control

Secondary Outcome Measures

Systolic and diastolic blood pressure control [24 mo]
fasting glycemic control [24 months]
Lipidic control [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo Cohen, Clinical Professor of Surgery, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01771185

Other Study ID Numbers:

HUUSP001

First Posted:

Jan 18, 2013

Last Update Posted:

Jan 18, 2013

Last Verified:

Jan 1, 2013

Keywords provided by Ricardo Cohen, Clinical Professor of Surgery, University of Sao Paulo

Diabetes

metabolic surgery

insulin resistance

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Metformin

Gliclazide

Study Results

No Results Posted as of Jan 18, 2013