The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes (TRIABETES)

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring 21+ years old, Address, Adult, Amputation, Area, Arm, Atheroscleroses, Atherosclerosis, Atherosclerotic, Cardiovascular Disease, Bariatrics, Behavior Conditioning Therapy, Behavior Modification, Behavior Therapy, Behavior Treatment, Behavior or Life Style Modifications, Behavioral, Behavioral Conditioning Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Beta Cell, Blindness, Blood Pressure, High, Blood Vessels, Body Composition, Body Weight decreased, Cancers, Cardiac infarction, Cardiovascular Diseases, Care, Health, Cause of Death, Cell Function, Cell Process, Cell physiology, Cellular Function, Cellular Physiology, Cellular Process, Cessation of life, Clinical, Clinical Trials Design, Communities, Conditioning Therapy, Controlled Clinical Trials, Randomized, Controlled Study, Country, D-Glucose, Death, Decision Making, Dextrose, Diabetes Mellitus, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Ketosis-Resistant, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Slow-Onset, Diabetes Mellitus, Stable, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type II, Diet, Disease, Disease remission, Disorder, Drugs, Dysfunction, Effectiveness, Epidemic, Functional disorder, Future, Gastric Bypass, Glucose, Health, Healthcare, Hepatic Disorder, Human, Adult, Hypertension, INFLM, Incidence, Inflammation, Insulin Cell, Insulin Resistance, Insulin Secreting Cell, Intestinal, Intestines, Intravenous Glucose Tolerance, Intravenous Glucose Tolerance Test, Kidney Failure, Kidney Insufficiency, Learning, Life Style, Life Style Modification, Lifestyle, Link, Liver diseases, Longitudinal Studies, MODY, Malignant Neoplasms, Malignant Tumor, Maturity-Onset Diabetes Mellitus, Measures, Medical, Medication, Metabolic, Methods, Modification, Morbid Obesity, Morbidity, Morbidity - disease rate, Mortality, Mortality Vital Statistics, Myocardial Infarct, Myocardial Infarction, NAFLD, NASH, NIDDM, Non-Insulin Dependent Diabetes, Non-Insulin-Dependent Diabetes Mellitus, Non-alcoholic steatohepatitis, Obesity, Obesity, Morbid, Operation, Operative Procedures, Operative Surgical Procedures, Outcome, Outcome Measure, PROV, Participant, Patients, Pharmaceutic Preparations, Pharmaceutical Preparations, Physical activity, Physiopathology, Pilot Projects, Population, Procedures, Programs (PT), Programs [Publication Type], Provider, Psychosocial Factor, Public Health, RMSN, Randomized, Randomized Controlled Clinical Trials, Randomized Controlled Trials, Remission, Renal Failure, Renal Insufficiency, Reporting, Resolution, Science, Severe obesity, Structure, Subcellular Process, Surgical, Surgical Interventions, Surgical Procedure, T2D, T2DM, Testing, Type 2 diabetes, Type II diabetes, United States, Upper arm, Vascular Hypertensive Disease, Vascular Hypertensive Disorder, Weight, Weight Loss, Weight Reduction, Work, adiposity, adult human (21+), adult onset diabetes, atheromatosis, atherosclerotic vascular disease, bariatric surgery, behavior intervention, behavioral intervention, blood glucose regulation, body weight loss, bowel, cardiac infarct, cardiovascular disorder, cardiovascular risk, cardiovascular risk factor, clinical practice, comparative effectiveness, coronary attack, coronary infarct, coronary infarction, corpulence, corpulency, corpulentia, design, designing, diabetes, diabetic patient, disease/disorder, drug/agent, effective therapy, effectiveness research, fitness, gastric banding, gastric bypass surgery, glucose control, glucose homeostasis, glucose metabolism, glucose regulation, heart attack, heart infarct, heart infarction, hepatopathy, hyperpiesia, hyperpiesis, hypertensive disease, implantable gastric stimulation banding, insulin resistant, interest, ketosis resistant diabetes, life style intervention, lifestyle intervention, liver disorder, long-term study, malignancy, maturity onset diabetes, moderate obesity, neoplasm/cancer, non-alcohol fatty liver, non-alcohol induced steatohepatitis, non-alcoholic fatty liver, non-alcoholic steato-hepatitis, nonalcohol fatty liver, nonalcoholic fatty liver, nonalcoholic steato-hepatitis, nonalcoholic steatohepatitis, obese, obese people, obese person, obese population, obesity surgery, obesity, extreme, pathophysiology, pilot study, programs, psychosocial, psychosocial variables, public health medicine (field), public health relevance, randomisation, randomization, randomized controlled study, randomized trial, randomly assigned, respiratory, response, stomach bypass, stomach stapling, surgery, trial comparing, vascular, weight loss intervention, weight loss surgery, wt-loss Read More

Inclusion Criteria:

• Age 25 to 55 years
• Mild to moderate obesity with a BMI between 30 and 40 kg/m2
• For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose > 126 mg/dl OR treatment with an anti-diabetic medication
• For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication
• Willingness to be randomized to a surgical intervention

Exclusion Criteria:

• Prior bariatric or foregut surgery
• Poor overall general health
• Impaired mental status
• Drug and/or alcohol addiction
• Current smoking
• Pregnant or plans to become pregnant
• Type 1 Diabetes Mellitus
• Portal hypertension and/or Cirrhosis
• Failed study-related nutrition or psychological assessment
• Current participation in any other research study
• Inability to provide informed consent
• Unlikely to comply with study protocol
• Unable to communicate with study staff
• Unable to exercise (walk a city block or a flight of stairs)