The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery \[either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy\] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Roux-en-Y gastric bypass
Laparoscopic sleeve gastrectomy
Cleveland Clinic
Cleveland, Ohio, United States
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.
The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Time frame: 1 year
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.
Time frame: 1 year
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Time frame: 1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
Time frame: 1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
Time frame: 1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Time frame: 1 year - baseline
Fasting Plasma Glucose
Fasting Plasma Glucose measured in mg/dL.
Time frame: 1 year
Glycated Hemoglobin (HbA1c)
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Time frame: 1 year
Body Weight
Body weight in kilograms (kg) measured at 12 months
Time frame: 1 year
Change in Body Weight From Baseline
Mean change in body weight from baseline measured in kilograms (kg)
Time frame: 1 year
Body Mass Index (BMI)
Body Mass Index (BMI) at 12 months measured as kg/m2
Time frame: 1 year
Change in Body Mass Index (BMI)
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Time frame: 1 year
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP) at 12 months
Time frame: 1 year
Change in High-density Lipoprotein (HDL)
Percent change in high-density lipoprotein (HDL) at 12 months
Time frame: 1 year
Change in Triglycerides
Median percent change in triglycerides at 12 months from baseline measure
Time frame: 1 year
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months
Time frame: 1 year
Diabetes Medication - Use of Insulin
Number of participants taking insulin at 12 months
Time frame: 1 year
Diabetes Medication - Use of Biguanides
Number of participants taking Biguanides at 12 months
Time frame: 1 year
Diabetes Medication - Use of Thiazolidinedione
Number of participants using thiazolidinedione at 12 months
Time frame: 1 year
Diabetes Medication - Use of Incretin Mimetics
Number of participants taking Incretin Mimetics
Time frame: 1 year
Diabetes Medication - Use of Secretagogue
Number of participants taking Secretagogues at 12 months
Time frame: 1 year
Cardiovascular Medications - Lipid Lowering Agents
Number of participants taking Lipid lowering agents at 12 months
Time frame: 1 year
Cardiovascular Medications - Beta Blocker
Number of participants taking Beta Blockers at 12 months
Time frame: 1 year
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)
Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Time frame: 1 year
Cardiovascular Medications - Anticoagulants
Number of participants taking anticoagulants at 12 months
Time frame: 1 year
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