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Status unknownNCT00540462T2DMUpdated Nov 14, 2008

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

A Phase 4 interventional study of gastric bypass and sleeve gastrectomy in Type II Diabetes Mellitus, sponsored by Min-Sheng General Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-11-14.

Sponsored by Min-Sheng General Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Type II Diabetes Mellitus

Keywords

  • Type II Diabetes Mellitus
  • Gastric bypass
  • Obese-related diabetes mellitus
  • Sugar control
  • treatment of obesity related diabetes mellitus
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Min-Sheng General Hospital is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • Proceduregastric bypass
  • Proceduresleeve gastrectomy
06

What researchers measure

Primary outcomes

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

    Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months

Secondary outcomes

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

    Time frame: 1 yr

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 21339423 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00540462
Lead sponsor
Min-Sheng General Hospital
First posted
Oct 8, 2007
Start date
Aug 2007
Primary completion
Aug 2008 (estimated)
Completion
Dec 2008 (estimated)
Last update
Nov 14, 2008

Study contacts

Lee WeiJei, M.D, Ph.D
Contact
wjlee_obessurg_tw@yahoo.com.tw
886-3-3179599 ext. 1599
Lee WeiJei, M.D, Ph.D
principal investigator · MSGH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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