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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

Tracking Information
First Submitted Date June 9, 2017
First Posted Date June 22, 2017
Last Update Posted Date June 22, 2017
Actual Study Start Date September 4, 2012
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 19, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
Official Title Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers in Class II and III Obesity
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population BMI 35- 69.9 Men and Women over age 25
Condition Obesity
Intervention Not Provided
Study Groups/Cohorts Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2017)
691
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2016
Actual Primary Completion Date September 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • BMI in the range of 35 - 69.9
  • Men and Women over age 25
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03195712
Other Study ID Numbers IRB 12-048x
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor St. Luke's-Roosevelt Hospital Center
Collaborators Not Provided
Investigators
Principal Investigator: Richard Weil, M.Ed Icahn School of Medicine at Mount Sinai
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date June 2017