Bariatric Surgery Candidate, Obesity, Type2 Diabetes
Conditions
Brief summary
The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes.
Detailed description
The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.
Interventions
PROCEDUREBariatric Surgery
Patients chosen using the following codes: Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type II diabetes * 18-80 years old * BMI\>=30 * HBA1c \>6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)
Exclusion criteria
* History of liver, heart, or lung transplant * Emergency department admission within 5 days prior * Cancer diagnosis within 1 year prior * Any prior ejection fraction \<20% * Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients) * Last follow-up date on or before the index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality and/or Cardiovascular Outcomes | From index date through a maximum of 8 years | First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Event (MACE-3) | From index date through a maximum of 8 years | First occurrence of all-cause mortality, myocardial infarction or ischemic stroke |
| All-Cause Mortality | From index date through a maximum of 8 years | Occurrence of death from any cause |
| Coronary Disease Events | From index date through a maximum of 8 years | First occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting |
| Cerebrovascular Events | From index date through a maximum of 8 years | First occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy |
| Heart Failure | From index date through a maximum of 8 years | First occurrence of heart failure |
| Development of Nephropathy | From index date through a maximum of 8 years | First occurrence of nephropathy defined as \>=2 measures of estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73m\^2 separated by at least 90 days without intervening values \>=60 |
| Atrial Fibrillation | From index date through a maximum of 8 years | First occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhil Schauer, MD
The Cleveland Clinic
Participant flow
Recruitment details
Retrospective chart review of 287, 428 patients with Diabetes in the Cleveland Clinic health system between 1998-2017
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.4 years |
| BMI | 42.6 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3245 Participants |
| Race (NIH/OMB) More than one race | 234 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 461 Participants |
| Race (NIH/OMB) White | 9728 Participants |
| Sex: Female, Male Female | 7339 Participants |
| Sex: Female, Male Male | 4096 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 112 / 2,287 | 1,111 / 11,435 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 169 / 2,287 | 0 / 0 |
Outcome results
None listed