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Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus (T2DM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Min-Sheng General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT00540462
First received: October 4, 2007
Last updated: November 13, 2008
Last verified: October 2008
History of Changes
  Purpose

Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass & sleeve gastrectomy) in obese-related diabetes.


Condition Intervention Phase
Type II Diabetes Mellitus
 Procedure: gastric bypass
Procedure: sleeve gastrectomy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:
  • Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Medical Group
Active Comparator: 2
Surgical Group with gastric bypass
 Procedure: gastric bypass
Active Comparator: 3
Sugical Group with Sleeve gastrectomy
 Procedure: sleeve gastrectomy

Detailed Description:

In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base on this observation, we will try to find out the role surgical intervention (gastric bypass and sleeve gastrectomy) in obese-related diabetes. With restriction of stomach volume and with or without duodenal exclusion, this randomized trials will find out the role of duodenal exclusion and the role of Ghrenin in obese-related type II DM patients. The initial observation of previous morbidly obese patients with type II DM, the DM seems a chronic disease which could be treated or controlled by surgical intervention, that's what we try to know more.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with diagnosis of T2DM for at least 6 months
  • Mild to moderate obesity status(BMI 27 - 35 )
  • Age : 30 - 60 year-old
  • HbA1C > 8 %

Exclusion Criteria:

  • With co-morbidity illness of cardiovascular system
  • DM related nephropathy (Cre >2.0 mg/dl)
  • Pulmonary embolism or uncontrolled coagulopathy in 6 months
  • HBV or HCV hepatitis or liver cirrhosis, inflammatory colon disease, Cushing syndrome
  • s/p organ transplantation
  • Previously Bariatric surgery, gastrointestinal surgery, or abdominal sepsis
  • Alcoholic or drug abuser
  • Psychological disease.
  • HIV or TB patient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540462

Contacts
Contact: Lee WeiJei, M.D, Ph.D 886-3-3179599 ext 1599 wjlee_obessurg_tw@yahoo.com.tw

Locations
Taiwan
MinSheng Genral Hospital Recruiting
Taoyuan, Taiwan
Contact: Lee WeiJei, M.D, Ph.D     886-3-3179599 ext 1599     wjlee_obessurg_tw@yahoo.com.tw    
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Lee WeiJei, M.D, Ph.D MSGH
  More Information

No publications provided by Min-Sheng General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT00540462     History of Changes
Other Study ID Numbers: Diabetes01
Study First Received: October 4, 2007
Last Updated: November 13, 2008
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by Min-Sheng General Hospital:
Type II Diabetes Mellitus
Gastric bypass
Obese-related diabetes mellitus
Sugar control
treatment of obesity related diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013