improving diabetes through lifestyle and surgery

Conditions: Obesity; Type 2 Diabetes

Summary: weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. the investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, roux-en-y gastric bypass surgery, and adjustable gastric banding) affects diabetes. while the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.


Eligibility criteria:
inclusion criteria: * bmi 30-40 kg/m2 at screening visit 1 * age 21-64 years * insured by collaborating insurance plan (employee health plan) * type 2 diabetes * medically safe to undergo surgery and approved by a psychologist * able to exercise at a moderate level * able to give informed consent * willing to accept randomization to each group * able to communicate (both written and oral) in english * willing to use reliable method of birth control during study and ≥18 months postop (if applicable) exclusion criteria: * prior bariatric surgery * prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair. * weight loss of ≥ 5% of body weight in the past 6 months * uncontrolled diabetes (hba1c\>8.5%) * untreated severe diabetic retinopathy * use of thiazolidinediones or insulin currently or within the past 3 months * uncontrolled blood pressure (\>160/100 -may be rescreened) * estimated glomerular filtration rate (gfr)\<30 * malignancy (except squamous or basal cell of the skin) in the past 5 years * mi, stroke or cardiovascular procedure within 12 months * known hiv positive or use of anti-hiv therapy (haart) * unstable angina * significant pulmonary disease with oxygen dependency * chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium) * use of prescription weight loss medication or over-the-counter orlistat in the past 6 months * other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss * history of severe depression requiring hospitalization in the past 12 months * severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders * current bulimia nervosa * unable or unwilling to use meal replacement products * consumption of \>14 alcoholic drinks/week or \> 5 drinks on more than 2 occasions in the past 12 months * use of illicit substances in the past 12 months * cigarette or cigar smoking in the past 2 months * pregnant or nursing within past 6 months * plans to become pregnant within 2 years * plans to relocate from the area within 1 year * another member of household is a study participant or staff in the trial

Keywords: obesity diabetes