Neuroendocrine Brake for Type 2 Diabetes Mellitus

Inclusion criteria

• - Male and female between 18 and 65 years.
• BMI 25.1 - 34.9.
• Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
• Diagnosis of T2DM for at least 3 years.
• Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
• HbA1c >/ 7.5 documented for at least 3 months.
• Stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
• Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
• Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.

Exclusion criteria

• Prior abdominal surgery, except laparoscopic cholecystectomy.
• Taking appetite suppressant.
• Severe eating disorders.
• Severe pulmonary, renal or cardiac disease.
• Obese due to a clinically diagnosed endocrine disorder.
• Subjects with impaired liver function.
• History of peptic ulcer disease.
• History of malignant disease.
• Use of prescription, over the counter or herbal weight loss products.
• Pregnant or planning on pregnancy while enrolled in study.