Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
19. Juni 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
691
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10025
- Mount Sinai St, Luke's
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
25 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
BMI 35- 69.9 Men and Women over age 25
Beschreibung
Inclusion Criteria:
- BMI in the range of 35 - 69.9
- Men and Women over age 25
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The association between BMI from 35 - 69.9 and Total cholesterol
Zeitfenster: 7 years
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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.
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7 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The association between BMI from 35 - 69.9 and HDL- cholesterol
Zeitfenster: 7 years
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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.
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7 years
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The association between BMI from 35 - 69.9 and LDL- cholesterol
Zeitfenster: 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.
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7 years
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The association between BMI from 35 - 69.9 and Triglycerides
Zeitfenster: 7 years
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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.
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7 years
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The association between BMI from 35 - 69.9 and Systolic Blood Pressure
Zeitfenster: 7 years
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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.
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7 years
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The association between BMI from 35 - 69.9 and Diastolic Blood Pressure
Zeitfenster: 7 years
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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.
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7 years
|
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The association between BMI from 35 - 69.9 and Fasting blood glucose
Zeitfenster: 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
Zeitfenster: 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.
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7 years
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Richard Weil, M.Ed, Icahn School of Medicine at Mount Sinai
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
4. September 2012
Primärer Abschluss (Tatsächlich)
30. September 2016
Studienabschluss (Tatsächlich)
30. September 2016
Studienanmeldedaten
Zuerst eingereicht
9. Juni 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2017
Zuerst gepostet (Tatsächlich)
22. Juni 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juni 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Juni 2017
Zuletzt verifiziert
1. Juni 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB 12-048x
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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