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

Min-Sheng General Hospital

Status and phase: Unknown; Phase 4

Conditions: Type II Diabetes Mellitus

Treatments: Procedure: gastric bypass; Procedure: sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00540462

Diabetes01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

1

No Intervention group

Description:

Medical Group

2

Active Comparator group

Description:

Surgical Group with gastric bypass

Treatment:

Procedure: gastric bypass

3

Active Comparator group

Description:

Sugical Group with Sleeve gastrectomy

Treatment:

Procedure: sleeve gastrectomy