Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

NCT03195712 | Completed

• 1 other identifier: IRB 12-048x
• Study Type: observational
• Target: 691
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

BMI; Obesity

Outcome Measures

Primary Outcomes (1)

• The association between BMI from 35 - 69.9 and Total cholesterol

  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 Outcomes (7)

• The association between BMI from 35 - 69.9 and HDL- cholesterol

  7 years

• The association between BMI from 35 - 69.9 and LDL- cholesterol

  7 years

• The association between BMI from 35 - 69.9 and Triglycerides

  7 years

• The association between BMI from 35 - 69.9 and Systolic Blood Pressure

  7 years

• The association between BMI from 35 - 69.9 and Diastolic Blood Pressure

  7 years

Study Arms (1)

Patients with Class II and III Obesity

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

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BMI 35- 69.9 Men and Women over age 25

You may qualify if:

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

Mount Sinai St, Luke's

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Weil, M.Ed

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 22, 2017
• Study Start: September 4, 2012
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

US (1)