Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Biliopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI > 35 vs. Medical Therapy
Brief Summary: It is generally held that ß-cell function is irreversibly lost already at the time the disease manifests itself and thereafter continues to decline linearly with time. Several studies, however, have documented the possibility that ß-cell function may be restored, at least partially, in type 2 diabetes. Of major relevance to the issue of ß-cell recovery in diabetes are the following findings:

* bariatric surgery in morbidly obese patients with type 2 diabetes can restore euglycaemia, the acute insulin response to glucose and insulin sensitivity;
* recent studies have reported that diabetic subjects return to euglycaemia and normal insulin levels within days after surgery, long before a significant weight loss has occurred; and
* whereas gastric bypass (GBP) improves insulin sensitivity in proportion to weight loss, bilio-pancreatic diversion (BPD) improves insulin action out of proportion to weight loss, i.e., it normalizes it at a time when patients are still markedly obese. Because RYGB is a predominantly restrictive procedure involving the foregut, whereas BPD is a predominantly malabsorptive procedure involving the distal gastro-intestinal (GI) tract, these findings suggest that the control of both insulin action and ß-cell function is influenced by signals originating from the GI tract.

The principal aim of this study is to verify the effect on type 2 diabetes mellitus (T2DM) of GBP and BPD, the two operations which have shown specific actions on glucose homeostasis control, in type 2 diabetic patients with BMI \> 35 kg/m2, and to compare this effect with matched T2DM control patients receiving the standard of medical care.


Options:
A: Inclusion Criteria:

* Type 2 diabetes mellitus with HbA1c \> 7.0%
* Body mass index \> 27 and \< 43 kg/m2
* Candidate for general anesthesia

Exclusion Criteria:

* Prior bariatric surgery of any kind
* Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
* Kidney disease or chronic renal insufficiency with a creatinine level \> 1.8 mg/dl
* Known history of chronic liver disease (except for NAFLD/NASH)
* Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
* Psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
* Severe pulmonary disease defined as FEV1 \< 50% of predicted value
* Pregnancy
B: Inclusion Criteria:

* patients with type 2 diabetes and BMI ≥35 kg.m-2
* age between 30 and 60 years
* duration of diabetes ≥ 5 years
* poor glycemic control (i.e., HbA1c ≥ 7.0%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)

Exclusion Criteria:

* pregnancy
* medical conditions requiring acute hospitalisation
* severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
* recent (within preceding 12 months) myocardial infarction, stroke or TIA
* unstable angina pectoris
* psychological conditions which may hamper patient's cooperation
* geographic inaccessibility
* any condition which, in the judgement of the Investigator, may make risky the participation in the study or bias the results
C: Inclusion Criteria:

* BMI 50-60 kg/m2

Exclusion Criteria:

* Prior obesity operation
* Prior major abdominal surgical procedure
* Severe disabling cardiopulmonary disease
* Malignancy
* Oral steroid treatment
* Condition associated with poor compliance
D: 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

Answer: B