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Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

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ClinicalTrials.gov Identifier: NCT03195712
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Brief Summary:
The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

Condition or disease
Obesity

Detailed Description:

A positive association between BMI and metabolic health risk is often presented graphically as a J-shaped curve with BMI on the x-axis and the biomarker of interest on the y-axis. However, BMI is frequently presented in the literature with a cut point of 35 on the x-axis, leading to the assumption that the steep association continues beyond a BMI of 35. This presentation does not capture the metabolically healthy individual with obesity.

In the population of men and women with class II and II obesity who the clinical team studied, it was examined that the association between BMI as a continuous variable from 35 to 69.9 and metabolic syndrome biomarkers (total-, low density, and high density cholesterol, triglycerides, systolic and diastolic blood pressure, fasting blood glucose, and glycosylated hemoglobin), the study team found no evidence for a positive correlation between BMI and TC, LDL-C, TG, and FBG. And while the study team did find positive and significant correlations between BMI and HDL-C, SBP, DBP, and HgbA1C, the effect sizes were small and arguably clinically insignificant.

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The clinical team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.


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Study Type : Observational
Actual Enrollment : 691 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers in Class II and III Obesity
Actual Study Start Date : September 4, 2012
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.



Primary Outcome Measures :
  1. The association between BMI from 35 - 69.9 and Total cholesterol [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and total cholesterol reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and total cholesterol a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.


Secondary Outcome Measures :
  1. The association between BMI from 35 - 69.9 and HDL- cholesterol [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and HDL-cholesterol reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and HDL-cholesterol a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  2. The association between BMI from 35 - 69.9 and LDL- cholesterol [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and LDL-cholesterol reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and LDL-cholesterol a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  3. The association between BMI from 35 - 69.9 and Triglycerides [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and triglycerides reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and triglycerides a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  4. The association between BMI from 35 - 69.9 and Systolic Blood Pressure [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and systolic blood pressure reported in mm/Hg. Resting blood pressure was performed by the patients' private physician at their private office and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and systolic blood pressure a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  5. The association between BMI from 35 - 69.9 and Diastolic Blood Pressure [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and diastolic blood pressure reported in mm/Hg. Resting blood pressure was performed by the patients' private physician at their private office and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and diastolic blood pressure a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  6. The association between BMI from 35 - 69.9 and Fasting blood glucose [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and fasting blood glucose reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and fasting blood glucose a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

  7. The association between BMI from 35 - 69.9 and Hemoglobin A1C [ Time Frame: 7 years ]
    The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and hemoglobin A1C reported in percent (%). Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and hemoglobin A1C a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
BMI 35- 69.9 Men and Women over age 25
Criteria

Inclusion Criteria:

  • BMI in the range of 35 - 69.9
  • Men and Women over age 25

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): NCT03195712


Locations
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United States, New York
Mount Sinai St, Luke's
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
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Principal Investigator: Richard Weil, M.Ed Icahn School of Medicine at Mount Sinai

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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT03195712     History of Changes
Other Study ID Numbers: IRB 12-048x
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Luke's-Roosevelt Hospital Center:
BMI
Obesity
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Obesity, Metabolically Benign
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases