Clinical trial NCT03195712: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: BMI
Obesity
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 691
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BMI 35- 69.9 Men and Women over age 25

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: The association between BMI from 35 - 69.9 and Total cholesterol
timeFrame: 7 years
Secondary outcomes:
measure: The association between BMI from 35 - 69.9 and HDL- cholesterol
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and LDL- cholesterol
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and Triglycerides
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and Systolic Blood Pressure
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and Diastolic Blood Pressure
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and Fasting blood glucose
timeFrame: 7 years
measure: The association between BMI from 35 - 69.9 and Hemoglobin A1C
timeFrame: 7 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St, Luke's
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Richard Weil, M.Ed
role: PRINCIPAL_INVESTIGATOR
References: