Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Diabetes Mellitus, Type 2, Obesity
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.
Interventions
PROCEDUREGastric bypass
Roux-en-Y gastric bypass
PROCEDURESleeve Gastrectomy
Laparoscopic sleeve gastrectomy
Sponsors
Ethicon Endo-Surgery
LifeScan
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Medications - Lipid Lowering Agents | 1 year | Number of participants taking Lipid lowering agents 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 |
| 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 |
| 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 |
| 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. | — |
| Diabetes Medication - Use of Secretagogue | 1 year | Number of participants taking Secretagogues at 12 months |
| 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 |
| 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 |
| Change in Glycated Hemoglobin (HbA1c) | 1 year - baseline | Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change |
| Cardiovascular Medications - Beta Blocker | 1 year | Number of participants taking Beta Blockers at 12 months |
Countries
United States
Participant flow
Recruitment details
Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.
Pre-assignment details
68 patients screened fail prior to randomization due to not meeting inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Medical Therapy Intensive medical therapy for diabetes | 50 |
| Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy | 50 |
| Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1 Year Follow-up | Misses 9 and 12 month visit | 2 | 0 | 0 |
| 1 Year Follow-up | Withdrawal by Subject | 7 | 0 | 1 |
Baseline characteristics
| Characteristic | Medical Therapy | Gastric Bypass | Sleeve Gastrectomy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 7.4 | 48.3 years STANDARD_DEVIATION 8.4 | 47.9 years STANDARD_DEVIATION 8 | 48.6 years STANDARD_DEVIATION 7.9 |
| body-mass index | 36.8 kg/m2 STANDARD_DEVIATION 3 | 37.0 kg/m2 STANDARD_DEVIATION 3.3 | 36.2 kg/m2 STANDARD_DEVIATION 3.9 | 36.7 kg/m2 STANDARD_DEVIATION 3.4 |
| Body-mass index < 35 BMI < 35 | 19 participants | 14 participants | 18 participants | 51 participants |
| Body-mass index < 35 BMI > / = 35 | 31 participants | 36 participants | 32 participants | 99 participants |
| Body weight | 106.5 kg STANDARD_DEVIATION 14.7 | 106.7 kg STANDARD_DEVIATION 14.8 | 100.8 kg STANDARD_DEVIATION 16.4 | 104.6 kg STANDARD_DEVIATION 15.4 |
| Cardiovascular medication - Anticoagulant Not taking Anticoagulants | 24 participant | 29 participant | 34 participant | 87 participant |
| Cardiovascular medication - Anticoagulant Taking Anticoagulants | 26 participant | 21 participant | 16 participant | 63 participant |
| Cardiovascular medication - Beta blocker Not taking Beta Blocker | 41 participant | 41 participant | 44 participant | 126 participant |
| Cardiovascular medication - Beta blocker Taking Beta Blocker | 9 participant | 9 participant | 6 participant | 24 participant |
| Cardiovascular medication - Lipid Lowering Agents Not taking Lipid Lowering Agent | 9 participants | 7 participants | 11 participants | 27 participants |
| Cardiovascular medication - Lipid Lowering Agents Taking Lipid Lowering Agent | 41 participants | 43 participants | 39 participants | 123 participants |
| Cardiovascular medications - ACE Inhibitors or ARB Not taking ACE Inhibitor or ARB | 20 participant | 18 participant | 25 participant | 63 participant |
| Cardiovascular medications - ACE Inhibitors or ARB Taking ACE Inhibitor or ARB | 30 participant | 32 participant | 25 participant | 87 participant |
| Diabetes medication - Incretin Mimetics Not taking Incretin Mimetics | 26 participants | 31 participants | 29 participants | 86 participants |
| Diabetes medication - Incretin Mimetics Taking Incretin Mimetics | 24 participants | 19 participants | 21 participants | 64 participants |
| Diabetes medication - Secretagogues Not taking Secretagogues | 32 participants | 33 participants | 31 participants | 96 participants |
| Diabetes medication - Secretagogues Taking Secretagogues | 18 participants | 17 participants | 19 participants | 54 participants |
| Diabetes medication - Thiazolidinedione (TZD's) Not taking TZD's | 30 participants | 25 participants | 33 participants | 88 participants |
| Diabetes medication - Thiazolidinedione (TZD's) Taking TZD's | 20 participants | 25 participants | 17 participants | 62 participants |
| Diabetic medication - Biguanides Not taking Biguanides | 4 participants | 8 participants | 8 participants | 20 participants |
| Diabetic medication - Biguanides Taking Biguanides | 46 participants | 42 participants | 42 participants | 130 participants |
| Diastolic blood pressure | 83.7 mmHg STANDARD_DEVIATION 11.5 | 81.8 mmHg STANDARD_DEVIATION 10.2 | 82.1 mmHg STANDARD_DEVIATION 11.5 | 82.5 mmHg STANDARD_DEVIATION 11 |
| Duration of diabetes | 8.9 Years STANDARD_DEVIATION 5.8 | 8.2 Years STANDARD_DEVIATION 5.5 | 8.5 Years STANDARD_DEVIATION 4.8 | 8.5 Years STANDARD_DEVIATION 5.4 |
| Fasting glucose | 169.6 mg/dL STANDARD_DEVIATION 59.1 | 188.9 mg/dL STANDARD_DEVIATION 67.6 | 177.6 mg/dL STANDARD_DEVIATION 70.3 | 178.7 mg/dL STANDARD_DEVIATION 65.9 |
| High-density lipoprotein cholesterol | 46.3 mg/dL STANDARD_DEVIATION 13.2 | 46.2 mg/dL STANDARD_DEVIATION 13.4 | 44.5 mg/dL STANDARD_DEVIATION 11.9 | 45.7 mg/dL STANDARD_DEVIATION 12.8 |
| History of dyslipidemia No | 14 participants | 6 participants | 10 participants | 30 participants |
| History of dyslipidemia Yes | 36 participants | 44 participants | 40 participants | 120 participants |
| History of hypertension No | 24 participants | 15 participants | 20 participants | 59 participants |
| History of hypertension Yes | 26 participants | 35 participants | 30 participants | 91 participants |
| Metabolic syndrome No | 4 participants | 5 participants | 3 participants | 12 participants |
| Metabolic syndrome Yes | 46 participants | 45 participants | 47 participants | 138 participants |
| Number of Diabetic Medications 0 | 1 participants | 1 participants | 1 participants | 3 participants |
| Number of Diabetic Medications 1 | 8 participants | 10 participants | 11 participants | 29 participants |
| Number of Diabetic Medications 2 | 11 participants | 13 participants | 14 participants | 38 participants |
| Number of Diabetic Medications 3 | 16 participants | 12 participants | 13 participants | 41 participants |
| Number of Diabetic Medications > / = 4 | 14 participants | 14 participants | 11 participants | 39 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black/African American | 12 participants | 13 participants | 14 participants | 39 participants |
| Race/Ethnicity, Customized Caucasian | 37 participants | 37 participants | 36 participants | 110 participants |
| Region of Enrollment United States | 50 participants | 50 participants | 50 participants | 150 participants |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 39 Participants | 99 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 11 Participants | 51 Participants |
| Smoker Non-smoker | 35 Participants | 30 Participants | 39 Participants | 104 Participants |
| Smoker Smoker | 15 Participants | 20 Participants | 11 Participants | 46 Participants |
| Systolic blood pressure | 137.5 mmHg STANDARD_DEVIATION 17.4 | 134.6 mmHg STANDARD_DEVIATION 18.7 | 136.2 mmHg STANDARD_DEVIATION 18.8 | 136.1 mmHg STANDARD_DEVIATION 18.3 |
| Triglycerides | 169.0 mg/dL | 167.0 mg/dL | 157.0 mg/dL | 166.5 mg/dL |
| Use of insulin Insulin dependent | 22 participants | 22 participants | 22 participants | 66 participants |
| Use of insulin Non-insulin dependent | 28 participants | 28 participants | 28 participants | 84 participants |
| Waist circumference | 114.5 cm STANDARD_DEVIATION 9.4 | 116.4 cm STANDARD_DEVIATION 9.2 | 114.0 cm STANDARD_DEVIATION 10.4 | 115.0 cm STANDARD_DEVIATION 9.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 43 | 48 / 50 | 49 / 49 |
| serious Total, serious adverse events | 4 / 43 | 16 / 50 | 7 / 49 |
Outcome results
Primary
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
Population: Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. | 5 participants |
| Gastric Bypass | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. | 21 participants |
| Sleeve Gastrectomy | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. | 18 participants |
p-value: 0.002Chi-squared
p-value: 0.008Chi-squared
p-value: 0.59Chi-squared
Primary
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
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications | 0 participants |
| Gastric Bypass | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications | 21 participants |
| Sleeve Gastrectomy | Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications | 13 participants |
Comparison: Medical Therapy vs. Gastric Bypassp-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.1Chi-squared
Secondary
Body Mass Index (BMI)
Body Mass Index (BMI) at 12 months measured as kg/m2
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Body Mass Index (BMI) | 34.4 kg/m2 | Standard Deviation 3.7 |
| Gastric Bypass | Body Mass Index (BMI) | 26.8 kg/m2 | Standard Deviation 3.2 |
| Sleeve Gastrectomy | Body Mass Index (BMI) | 27.2 kg/m2 | Standard Deviation 3.5 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.61ANOVA
Secondary
Body Weight
Body weight in kilograms (kg) measured at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Body Weight | 99.0 kg | Standard Deviation 16.4 |
| Gastric Bypass | Body Weight | 77.3 kg | Standard Deviation 13 |
| Sleeve Gastrectomy | Body Weight | 75.5 kg | Standard Deviation 12.9 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.02ANOVA
Secondary
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
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) | 26 participants |
| Gastric Bypass | Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) | 9 participants |
| Sleeve Gastrectomy | Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) | 11 participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.62Chi-squared
Secondary
Cardiovascular Medications - Anticoagulants
Number of participants taking anticoagulants at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Cardiovascular Medications - Anticoagulants | 24 participants |
| Gastric Bypass | Cardiovascular Medications - Anticoagulants | 1 participants |
| Sleeve Gastrectomy | Cardiovascular Medications - Anticoagulants | 8 participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.03Chi-squared
Secondary
Cardiovascular Medications - Beta Blocker
Number of participants taking Beta Blockers at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Cardiovascular Medications - Beta Blocker | 5 participants |
| Gastric Bypass | Cardiovascular Medications - Beta Blocker | 9 participants |
| Sleeve Gastrectomy | Cardiovascular Medications - Beta Blocker | 3 participants |
p-value: 0.48Chi-squared
p-value: 0.46Chi-squared
p-value: 0.06Chi-squared
Secondary
Cardiovascular Medications - Lipid Lowering Agents
Number of participants taking Lipid lowering agents at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Cardiovascular Medications - Lipid Lowering Agents | 36 participants |
| Gastric Bypass | Cardiovascular Medications - Lipid Lowering Agents | 13 participants |
| Sleeve Gastrectomy | Cardiovascular Medications - Lipid Lowering Agents | 19 participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.2Chi-squared
Secondary
Change in Body Mass Index (BMI)
Change in Body Mass Index (BMI) at 12 months, measured in kg/m2
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in Body Mass Index (BMI) | -1.9 kg/m2 | Standard Deviation 2.9 |
| Gastric Bypass | Change in Body Mass Index (BMI) | -10.2 kg/m2 | Standard Deviation 3.1 |
| Sleeve Gastrectomy | Change in Body Mass Index (BMI) | -9.0 kg/m2 | Standard Deviation 2.7 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.03ANOVA
Secondary
Change in Body Weight From Baseline
Mean change in body weight from baseline measured in kilograms (kg)
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in Body Weight From Baseline | -5.4 kg | Standard Deviation 8 |
| Gastric Bypass | Change in Body Weight From Baseline | -29.4 kg | Standard Deviation 8.9 |
| Sleeve Gastrectomy | Change in Body Weight From Baseline | -25.1 kg | Standard Deviation 8.5 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.02ANOVA
Secondary
Change in Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change
Time frame: 1 year - baseline
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in Glycated Hemoglobin (HbA1c) | -1.4 percentage points of glycated hemoglobin | Standard Deviation 1.5 |
| Gastric Bypass | Change in Glycated Hemoglobin (HbA1c) | -2.9 percentage points of glycated hemoglobin | Standard Deviation 1.6 |
| Sleeve Gastrectomy | Change in Glycated Hemoglobin (HbA1c) | -2.9 percentage points of glycated hemoglobin | Standard Deviation 1.8 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.85ANOVA
Secondary
Change in High-density Lipoprotein (HDL)
Percent change in high-density lipoprotein (HDL) at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in High-density Lipoprotein (HDL) | 11.3 mg/dL | Standard Deviation 25.7 |
| Gastric Bypass | Change in High-density Lipoprotein (HDL) | 28.5 mg/dL | Standard Deviation 22.7 |
| Sleeve Gastrectomy | Change in High-density Lipoprotein (HDL) | 28.4 mg/dL | Standard Deviation 21.9 |
p-value: 0.001ANOVA
p-value: 0.001ANOVA
p-value: 0.98ANOVA
Secondary
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
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Therapy | Change in High-sensitivity C-reactive Protein (Hs-CRP) | -33.2 mg/L |
| Gastric Bypass | Change in High-sensitivity C-reactive Protein (Hs-CRP) | -84 mg/L |
| Sleeve Gastrectomy | Change in High-sensitivity C-reactive Protein (Hs-CRP) | -80 mg/L |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.59Wilcoxon (Mann-Whitney)
Secondary
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP) at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Change in Systolic Blood Pressure (SBP) | -3.9 mm Hg | Standard Deviation 14.7 |
| Gastric Bypass | Change in Systolic Blood Pressure (SBP) | -2.4 mm Hg | Standard Deviation 18.7 |
| Sleeve Gastrectomy | Change in Systolic Blood Pressure (SBP) | -5.1 mm Hg | Standard Deviation 17 |
p-value: 0.87ANOVA
p-value: 0.67ANOVA
p-value: 0.46ANOVA
Secondary
Change in Triglycerides
Median percent change in triglycerides at 12 months from baseline measure
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Therapy | Change in Triglycerides | -14 mg/dL |
| Gastric Bypass | Change in Triglycerides | -44 mg/dL |
| Sleeve Gastrectomy | Change in Triglycerides | -42 mg/dL |
p-value: 0.002Wilcoxon (Mann-Whitney)
p-value: 0.08Wilcoxon (Mann-Whitney)
p-value: 0.17Wilcoxon (Mann-Whitney)
Secondary
Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.
Time frame: 1, 2, and 5 years
Secondary
Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).
Time frame: 1, 2, and 5 years
Secondary
Diabetes Medication - Use of Biguanides
Number of participants taking Biguanides at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Diabetes Medication - Use of Biguanides | 38 participants |
| Gastric Bypass | Diabetes Medication - Use of Biguanides | 10 participants |
| Sleeve Gastrectomy | Diabetes Medication - Use of Biguanides | 19 participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.05Chi-squared
Secondary
Diabetes Medication - Use of Incretin Mimetics
Number of participants taking Incretin Mimetics
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Diabetes Medication - Use of Incretin Mimetics | 34 participants |
| Gastric Bypass | Diabetes Medication - Use of Incretin Mimetics | 1 participants |
| Sleeve Gastrectomy | Diabetes Medication - Use of Incretin Mimetics | 10 participants |
p-value: <0.001Chi-squared
p-value: 0.005Chi-squared
p-value: 0.004Chi-squared
Secondary
Diabetes Medication - Use of Insulin
Number of participants taking insulin at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Diabetes Medication - Use of Insulin | 15 participants |
| Gastric Bypass | Diabetes Medication - Use of Insulin | 2 participants |
| Sleeve Gastrectomy | Diabetes Medication - Use of Insulin | 4 participants |
p-value: <0.001Chi-squared
p-value: 1.001Chi-squared
p-value: 0.68Chi-squared
Secondary
Diabetes Medication - Use of Secretagogue
Number of participants taking Secretagogues at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Diabetes Medication - Use of Secretagogue | 10 participants |
| Gastric Bypass | Diabetes Medication - Use of Secretagogue | 1 participants |
| Sleeve Gastrectomy | Diabetes Medication - Use of Secretagogue | 5 participants |
p-value: <0.001Chi-squared
p-value: 0.06Chi-squared
p-value: 0.2Chi-squared
Secondary
Diabetes Medication - Use of Thiazolidinedione
Number of participants using thiazolidinedione at 12 months
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Diabetes Medication - Use of Thiazolidinedione | 20 participants |
| Gastric Bypass | Diabetes Medication - Use of Thiazolidinedione | 0 participants |
| Sleeve Gastrectomy | Diabetes Medication - Use of Thiazolidinedione | 5 participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.06Chi-squared
Secondary
Fasting Plasma Glucose
Fasting Plasma Glucose measured in mg/dL.
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Therapy | Fasting Plasma Glucose | 120 mg/dL |
| Gastric Bypass | Fasting Plasma Glucose | 99 mg/dL |
| Sleeve Gastrectomy | Fasting Plasma Glucose | 97 mg/dL |
p-value: 0.004Wilcoxon (Mann-Whitney)
p-value: 0.003Wilcoxon (Mann-Whitney)
p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
Glycated Hemoglobin (HbA1c)
Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points
Time frame: 1 year
Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Therapy | Glycated Hemoglobin (HbA1c) | 7.5 percentage points of glycated hemoglobin | Standard Deviation 1.8 |
| Gastric Bypass | Glycated Hemoglobin (HbA1c) | 6.4 percentage points of glycated hemoglobin | Standard Deviation 0.9 |
| Sleeve Gastrectomy | Glycated Hemoglobin (HbA1c) | 6.6 percentage points of glycated hemoglobin | Standard Deviation 1 |
p-value: <0.001ANOVA
p-value: 0.003ANOVA
p-value: 0.23ANOVA
Secondary
The Cost-effectiveness of Each Program and the Side Effects and /or Complications.
Time frame: 1, 2, and 5 years.