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

NCT ID: NCT00540462

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Type II Diabetes Mellitus

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Medical Group

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Surgical Group with gastric bypass

Group Type ACTIVE_COMPARATOR

gastric bypass

Intervention Type PROCEDURE

3

Sugical Group with Sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

Interventions

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gastric bypass

Intervention Type PROCEDURE

sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Min-Sheng General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min-Sheng General Hospital

Principal Investigators

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Lee WeiJei, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

MSGH

Locations

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MinSheng Genral Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lee WeiJei, M.D, Ph.D

Role: CONTACT

Phone: 886-3-3179599

Email: [email protected]

Facility Contacts

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Lee WeiJei, M.D, Ph.D

Role: primary

References

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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.

Reference Type DERIVED
PMID: 21339423 (View on PubMed)

Other Identifiers

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Diabetes01

Identifier Type: -

Identifier Source: org_study_id