Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

June 19, 2017 updated by: St. Luke's-Roosevelt Hospital Center

Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers in Class II and III Obesity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
691

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • Mount Sinai St, Luke's

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

BMI 35- 69.9 Men and Women over age 25

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
7 years
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.
7 years
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.
7 years
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.
7 years
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.
7 years
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 years
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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Luke's-Roosevelt Hospital Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Weil, M.Ed, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 12-048x

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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