Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

NCT ID: NCT03195712

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 691 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-04
• Study Completion Date: 2016-09-30

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.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with Class II and III Obesity

Patients enrolled in an outpatient weight loss program from 2010-2016.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Weil, M.Ed

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai St, Luke's

New York, New York, United States

Countries

United States

Other Identifiers

IRB 12-048x

Identifier Type: -

Identifier Source: org_study_id