Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

Not Applicable

Completed

Conditions: Obesity
Diabetes Mellitus, Type 2

Interventions: Procedure: Sleeve Gastrectomy
Procedure: Gastric bypass

Registration Number: NCT00432809

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

Inclusion Criteria

Type 2 diabetes mellitus with HbA1c > 7.0%
Body mass index > 27 and < 43 kg/m2
Candidate for general anesthesia

Exclusion Criteria

Prior bariatric surgery of any kind
Cardiovascular conditions including significant coronary artery disease, peripheral vascular disease, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension
Kidney disease or chronic renal insufficiency with a creatinine level > 1.8 mg/dl
Known history of chronic liver disease (except for NAFLD/NASH)
Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months
Severe pulmonary disease defined as FEV1 < 50% of predicted value
Pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve Gastrectomy	Sleeve Gastrectomy	Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Gastric Bypass	Gastric bypass	Procedure/Surgery: Bariatric surgery laparoscipic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy

Primary Outcome Measures

Name	Time	Method
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.	1 year	The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications	1 year	The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.

Secondary Outcome Measures

Name	Time	Method
Diabetes Medication - Use of Insulin	1 year	Number of participants taking insulin at 12 months
Diabetes Medication - Use of Biguanides	1 year	Number of participants taking Biguanides at 12 months
Cardiovascular Medications - Beta Blocker	1 year	Number of participants taking Beta Blockers at 12 months
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)	1 year	Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months
Cardiovascular Medications - Anticoagulants	1 year	Number of participants taking anticoagulants at 12 months
Cardiovascular Medications - Lipid Lowering Agents	1 year	Number of participants taking Lipid lowering agents at 12 months
Diabetes Medication - Use of Thiazolidinedione	1 year	Number of participants using thiazolidinedione at 12 months
Diabetes Medication - Use of Incretin Mimetics	1 year	Number of participants taking Incretin Mimetics
Diabetes Medication - Use of Secretagogue	1 year	Number of participants taking Secretagogues at 12 months
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).	1, 2, and 5 years
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.	1, 2, and 5 years
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.	1, 2, and 5 years.
Change in Glycated Hemoglobin (HbA1c)	1 year - baseline	Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Fasting Plasma Glucose	1 year	Fasting Plasma Glucose measured in mg/dL.
Glycated Hemoglobin (HbA1c)	1 year	Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Body Weight	1 year	Body weight in kilograms (kg) measured at 12 months
Change in Body Weight From Baseline	1 year	Mean change in body weight from baseline measured in kilograms (kg)
Body Mass Index (BMI)	1 year	Body Mass Index (BMI) at 12 months measured as kg/m2
Change in Body Mass Index (BMI)	1 year	Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Change in Systolic Blood Pressure (SBP)	1 year	Change in Systolic Blood Pressure (SBP) at 12 months
Change in High-density Lipoprotein (HDL)	1 year	Percent change in high-density lipoprotein (HDL) at 12 months
Change in Triglycerides	1 year	Median percent change in triglycerides at 12 months from baseline measure
Change in High-sensitivity C-reactive Protein (Hs-CRP)	1 year	Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months