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Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03955952
Recruitment Status : Enrolling by invitation
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Schauer, The Cleveland Clinic

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. 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.

Condition or disease Intervention/treatment
Obesity Type2 Diabetes Bariatric Surgery Candidate Procedure: Bariatric Surgery

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Study Type : Observational
Actual Enrollment : 13722 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus Usual Care
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bariatric Surgery
Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery
Procedure: Bariatric 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


Non-Surgical Control
Matched non-surgical controls with type 2 diabetes and BMI >=30



Primary Outcome Measures :
  1. Composite of All-Cause Mortality and Cardiovascular Outcomes [ Time Frame: From index date through a maximum of 10 years ]
    Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation


Secondary Outcome Measures :
  1. Incidence of Major Adverse Cardiovascular Event (MACE-3) [ Time Frame: From index date through a maximum of 10 years ]
    Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke

  2. All-Cause Mortality [ Time Frame: From index date through a maximum of 10 years ]
    Time to occurrence of death from any cause

  3. Incidence of Coronary Disease Events [ Time Frame: From index date through a maximum of 10 years ]
    Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting

  4. Incidence of Cerebrovascular Events [ Time Frame: From index date through a maximum of 10 years ]
    Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy

  5. Incidence of Heart Failure [ Time Frame: From index date through a maximum of 10 years ]
    Time to first occurrence of heart failure

  6. Development of Nephropathy [ Time Frame: From index date through a maximum of 10 years ]
    Time to 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

  7. Incidence of Atrial Fibrillation [ Time Frame: From index date through a maximum of 10 years ]

    Time to 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



Other Outcome Measures:
  1. Percentage Change in Body Weight [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in body weight from index date to years 1, 3 and 5 post-index date

  2. Percentage Change in Hemoglobin A1c [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in hemoglobin A1c from index date to years 1, 3 and 5 post-index date

  3. Percentage Change in Systolic Blood Pressure (SBP) [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in SBP from index date to years 1, 3 and 5 post-index date

  4. Percentage Change in Diastolic Blood Pressure (DBP) [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in DBP from index date to years 1, 3 and 5 post-index date

  5. Percentage Change in High Density Lipoprotein (HDL) [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in HDL from index date to years 1, 3 and 5 post-index date

  6. Percentage Change in Low Density Lipoprotein (LDL) [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in LDL from index date to years 1, 3 and 5 post-index date

  7. Percentage Change in Triglycerides [ Time Frame: 1,3 and 5 years post-index date ]
    Percentage change in triglycerides from index date to years 1, 3 and 5 post-index date



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes patients with obesity (BMI>=30) between 18-80 years old.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955952


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Phil Schauer, MD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philip Schauer, Director of Bariatric and Metabolic Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03955952     History of Changes
Other Study ID Numbers: 19-066
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms