N/A
N=150
Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Diabetes Mellitus, Type 2 · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00432809 ↗Enrolled (actual)
150
Serious AEs
19.0%
Results posted
Jun 2013
Primary outcome: Primary: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. — 5; 21; 18 participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gastric bypass (Procedure); Sleeve Gastrectomy (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. |
5; 21; 18 | 0.002 sig |
| PRIMARY Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications |
0; 21; 13 | <0.001 sig |
| SECONDARY Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance). |
— | — |
| SECONDARY Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations. |
— | — |
| SECONDARY The Cost-effectiveness of Each Program and the Side Effects and /or Complications. |
— | — |
| SECONDARY Change in Glycated Hemoglobin (HbA1c) |
-1.4; -2.9; -2.9 | <0.001 sig |
| SECONDARY Fasting Plasma Glucose |
120; 99; 97 | 0.004 sig |
| SECONDARY Glycated Hemoglobin (HbA1c) |
7.5; 6.4; 6.6 | <0.001 sig |
| SECONDARY Body Weight |
99.0; 77.3; 75.5 | <0.001 sig |
| SECONDARY Change in Body Weight From Baseline |
-5.4; -29.4; -25.1 | <0.001 sig |
| SECONDARY Body Mass Index (BMI) |
34.4; 26.8; 27.2 | <0.001 sig |
| SECONDARY Change in Body Mass Index (BMI) |
-1.9; -10.2; -9.0 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
-3.9; -2.4; -5.1 | 0.87 |
| SECONDARY Change in High-density Lipoprotein (HDL) |
11.3; 28.5; 28.4 | 0.001 sig |
| SECONDARY Change in Triglycerides |
-14; -44; -42 | 0.002 sig |
| SECONDARY Change in High-sensitivity C-reactive Protein (Hs-CRP) |
-33.2; -84; -80 | <0.001 sig |
| SECONDARY Diabetes Medication - Use of Insulin |
15; 2; 4 | <0.001 sig |
| SECONDARY Diabetes Medication - Use of Biguanides |
38; 10; 19 | <0.001 sig |
| SECONDARY Diabetes Medication - Use of Thiazolidinedione |
20; 0; 5 | <0.001 sig |
| SECONDARY Diabetes Medication - Use of Incretin Mimetics |
34; 1; 10 | <0.001 sig |
| SECONDARY Diabetes Medication - Use of Secretagogue |
10; 1; 5 | <0.001 sig |
| SECONDARY Cardiovascular Medications - Lipid Lowering Agents |
36; 13; 19 | <0.001 sig |
| SECONDARY Cardiovascular Medications - Beta Blocker |
5; 9; 3 | 0.48 |
| SECONDARY Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB) |
26; 9; 11 | <0.001 sig |
| SECONDARY Cardiovascular Medications - Anticoagulants |
24; 1; 8 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus with HbA1c > 7.0%
- Body mass index > 27 and 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
Data sourced from ClinicalTrials.gov (NCT00432809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.