Metabolic Effects of Gastrointestinal Surgery in T2DM

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ricardo Cohen, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01771185
First received: January 14, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ricardo Cohen, Clinical Professor of Surgery, University of Sao Paulo
ClinicalTrials.gov 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:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014