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

Primary Purpose

Type II Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
gastric bypass
sleeve gastrectomy
Sponsored by
Min-Sheng General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, Sugar control, treatment of obesity related diabetes mellitus

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MinSheng Genral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Medical Group

Surgical Group with gastric bypass

Sugical Group with Sleeve gastrectomy

Outcomes

Primary Outcome Measures

Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.

Secondary Outcome Measures

Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy

Full Information

First Posted
October 4, 2007
Last Updated
November 13, 2008
Sponsor
Min-Sheng General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00540462
Brief Title
Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
Acronym
T2DM
Official Title
Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Min-Sheng General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, Sugar control, treatment of obesity related diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Medical Group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical Group with gastric bypass
Arm Title
3
Arm Type
Active Comparator
Arm Description
Sugical Group with Sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
gastric bypass
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Primary Outcome Measure Information:
Title
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
Secondary Outcome Measure Information:
Title
Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy
Time Frame
1 yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee WeiJei, M.D, Ph.D
Phone
886-3-3179599
Ext
1599
Email
wjlee_obessurg_tw@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee WeiJei, M.D, Ph.D
Organizational Affiliation
MSGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
MinSheng Genral Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee WeiJei, M.D, Ph.D
Phone
886-3-3179599
Ext
1599
Email
wjlee_obessurg_tw@yahoo.com.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
21339423
Citation
Lee WJ, Chong K, Ser KH, Lee YC, Chen SC, Chen JC, Tsai MH, Chuang LM. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg. 2011 Feb;146(2):143-8. doi: 10.1001/archsurg.2010.326.
Results Reference
derived

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

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