Clinical trial NCT00540462: Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
Official title: Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus
Gastric bypass
Obese-related diabetes mellitus
Sugar control
treatment of obesity related diabetes mellitus
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
First posted: 2007-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
Secondary outcomes:
measure: Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy
timeFrame: 1 yr
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: MinSheng Genral Hospital
Study officials:
affiliation: MSGH
name: Lee WeiJei, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.