Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
19 giugno 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
691
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
New York
-
New York, New York, Stati Uniti, 10025
- Mount Sinai St, Luke's
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 25 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
BMI 35- 69.9 Men and Women over age 25
Descrizione
Inclusion Criteria:
- BMI in the range of 35 - 69.9
- Men and Women over age 25
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The association between BMI from 35 - 69.9 and Total cholesterol
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The association between BMI from 35 - 69.9 and HDL- cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Richard Weil, M.Ed, Icahn School of Medicine at Mount Sinai
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
4 settembre 2012
Completamento primario (Effettivo)
30 settembre 2016
Completamento dello studio (Effettivo)
30 settembre 2016
Date di iscrizione allo studio
Primo inviato
9 giugno 2017
Primo inviato che soddisfa i criteri di controllo qualità
19 giugno 2017
Primo Inserito (Effettivo)
22 giugno 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 giugno 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 giugno 2017
Ultimo verificato
1 giugno 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB 12-048x
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .