Clinical Trials Directory

Trials / Completed

CompletedNCT03195712

Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

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

Status
Completed
Phase
Study type
Observational
Enrollment
691 (actual)
Sponsor
St. Luke's-Roosevelt Hospital Center · Academic / Other
Sex
All
Age
25 Years – 75 Years
Healthy volunteers
Accepted

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

Timeline

Start date
2012-09-04
Primary completion
2016-09-30
Completion
2016-09-30
First posted
2017-06-22
Last updated
2017-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03195712. Inclusion in this directory is not an endorsement.