Evaluation of Intra-Abdominal Fat Extraction Using HydraSolve T2D™ in Obese Subjects With Type 2 Diabetes

Exclusion Criteria

• •1\. Premenopausal females.
• •2\. Tobacco use.
• •3\. Current drug or ETOH abuse.
• •4\. Uncontrolled psychiatric illness.
• •5\. Abnormal T4 and TSH found in screening blood test.
• •6\. Subjects who have contraindications to major abdominal surgery are excluded.
• •7\. Serum albumin \<35 g/L
• •8\. Body weight loss \>5% during the 6 month time period preceding the anticipated surgery date.
• •9\. Presence of a remote body site infection. (Examples: dental urinary, skin soft tissue)
• •10\. History of cholecystitis, hepatitis or NASH.
• •11\. History of ulcerative colitis, Crohn's disease, or diverticulitis.
• •12\. History of respiratory conditions that are not controllable without the use of chronic or intermittent steroid use; such as poorly controlled asthma or COPD.
• •13\. Chemistry, liver enzyme and function, and hematology levels that are outside of the normal range. (Fasting glucose may be elevated but subject will be excluded if it is ≥ 250 mg/dl.)
• •14\. LDL ≥ 180 mg/dl.
• •15\. Triglycerides ≥ 400 mg/dl.
• •16\. A diagnosis of Cushing's disease. (If a potential subject does not have a diagnosis of Cushing's disease, and the examining endocrinologist detects concerning signs or symptoms that lead him/her to suspect that the potential subject may have Cushing's disease (based on the subject's history, review of systems and physical exam) then that potential subject will be excluded from the study and referred back to his/her primary care physician for further evaluation.)
• •17\. Anemia, hemoglobinopathy or any conditions that increase red blood cell turnover.
• •18\. Recent history of receiving a blood transfusion.
• •19\. Recent history of donating blood.
• •20\. Clinically significant major organ disease as determined by medical history, physical exam, screening blood tests, urinalysis, and EKG.
• •21\. History of prior abdominal/pelvic surgery, or prior OB/GYN surgery.
• •22\. Uncontrolled comorbidity. (Example: uncontrolled hypertension.)
• •23\. Large umbilical hernia. (This does not include small umbilical hernias that are fat containing only; subjects with this specific type of hernia are allowed in the study, and this type of hernia could be managed and closed primarily with closure of the surgical site.)
• •24\. Large ventral hernia.
• •25\. Use of insulin.
• •26\. Anticoagulation or antiplatelet therapies.
• •27\. History of gastrointestinal cancer.
• •28\. Limited life expectancy.