Mannheim Obesity Study (MOS)

This study is currently recruiting participants.
Verified March 2013 by Universitätsmedizin Mannheim
Sponsor:
Information provided by (Responsible Party):
Alexander Lammert, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00770276
First received: October 8, 2008
Last updated: March 9, 2013
Last verified: March 2013
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Metabolic syndrome [ Time Frame: baseline, after 1 and 2 years ] [ Designated as safety issue: No ]
  • Framingham risk score [ Time Frame: baseline, 1 and 2 years ] [ Designated as safety issue: No ]
  • Subclinical atherosclerosis (IMT) [ Time Frame: baseline, 1 and 2 years ] [ Designated as safety issue: No ]
  • Endothelial dysfunction [ Time Frame: baseline, 1 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: baseline, 1 and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2005
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bariatric surgery
Bariatric surgery
conservative Therapie
diet and exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770276

Contacts
Contact: Hans-Peter Hammes, MD +496213832663 hans-peter.hammes@med5.ma.uni-heidelberg.de
Contact: Alexander Lammert +496213832317 alexander.lammert@med5.ma.uni-heidelberg.de

Locations
Germany
University hospital of Mannheim Recruiting
Mannheim, BW, Germany, 68167
Contact: Hans-Peter Hammes, MD    +496213832663    hans-peter.hammes@med5.uni-heidelberg.de   
Principal Investigator: Alexander Lammert         
Principal Investigator: Petra Stuebler, MD         
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

Publications:

Responsible Party: Alexander Lammert, Dr. med., University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00770276     History of Changes
Other Study ID Numbers: MOS
Study First Received: October 8, 2008
Last Updated: March 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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

ClinicalTrials.gov processed this record on April 23, 2014