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Mannheim Obesity Study (MOS)

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ClinicalTrials.gov Identifier: NCT00770276
Recruitment Status : Active, not recruiting
First Posted : October 9, 2008
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander Lammert, Universitätsmedizin Mannheim

Brief Summary:

MOPS: Mannheim Obesity Pilot Study

Introduction:

Obesity is a central feature of the metabolic syndrome. With increasing prevalence of overweight and obesity, the incidence of WHO III° obesity will further augment. In this subset of obese patients, metabolic complications and cardiovascular risk are major clinical issues. Epidemiological data show that with increased BMI mortality rises (1). The SOS-Study demonstrated, for the first time, that bariatric surgery and consecutive weight reduction are associated with a decrease in cardiovascular and overall mortality. Significant mortality in this study was caused by cardiovascular events and cancer.

Metabolic Syndrome - MS - Despite varying definitions of the metabolic syndrome, obesity is one of its central features. Depending on the definition used, it can represent an obligate criterion (IDF) or a facultative parameter (WHO and ATP III). Even though not obligate, extreme obesity is a central risk factor for most other parameters of the metabolic syndrome.

Endothelial dysfunction -ED- represents the initial step of atherosclerosis (3). An appropriate measurement is the evaluation by retinal analysis. Epidemiological data demonstrate increased cardiovascular risk with retinal vessel pathology (4).


Condition or disease
Obesity

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity
Study Start Date : January 2005
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : January 2020

Group/Cohort
Bariatric surgery
Bariatric surgery
conservative Therapie
diet and exercise



Primary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: baseline, after 1 and 2 years ]
  2. Framingham risk score [ Time Frame: baseline, 1 and 2 years ]
  3. Subclinical atherosclerosis (IMT) [ Time Frame: baseline, 1 and 2 years ]
  4. Endothelial dysfunction [ Time Frame: baseline, 1 and 2 years ]

Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: baseline, 1 and 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
outpatient department of an university hospital
Criteria

Inclusion Criteria:

  • obesity WHO I-III

Exclusion Criteria:

  • pregnancy
  • acute vascular event within the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770276


Locations
Germany
University hospital of Mannheim
Mannheim, BW, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander Lammert, Dr. med., Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT00770276     History of Changes
Other Study ID Numbers: MOS
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Alexander Lammert, Universitätsmedizin Mannheim:
obesity WHO I-III
metabolic syndrome
Framingham risk score
subclinical atherosclerosis
endothelial dysfunction

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms