Mannheim Obesity Study - Full Text View

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:

MedlinePlus related topics: Atherosclerosis Metabolic Syndrome Obesity Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by University Hospital 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

University Hospital Mannheim

More Information

Publications:

Lammert A, Hasenberg T, Kräupner C, Schnülle P, Hammes HP. Improved arteriole-to-venule ratio of retinal vessels resulting from bariatric surgery. Obesity (Silver Spring). 2012 Nov;20(11):2262-7. doi: 10.1038/oby.2012.122. Epub 2012 May 4.

Lammert A, Hasenberg T, Imhof I, Schnülle P, Benck U, Krämer BK, Hammes HP. High prevalence of retinal endothelial dysfunction in obesity WHO class III. Microvasc Res. 2012 Nov;84(3):362-6. doi: 10.1016/j.mvr.2012.09.004. Epub 2012 Sep 23.

Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105.

Burguera B, Agusti A, Arner P, Baltasar A, Barbe F, Barcelo A, Breton I, Cabanes T, Casanueva FF, Couce ME, Dieguez C, Fiol M, Fernandez Real JM, Formiguera X, Fruhbeck G, Garcia Romero M, Garcia Sanz M, Ghigo E, Gomis R, Higa K, Ibarra O, Lacy A, Larrad A, Masmiquel L, Moizé V, Moreno B, Moreiro J, Ricart W, Riesco M, Salinas R, Salvador J, Pi-Sunyer FX, Scopinaro N, Sjostrom L, Pagan A, Pereg V, Sánchez Pernaute A, Torres A, Urgeles JR, Vidal-Puig A, Vidal J, Vila M. Critical assessment of the current guidelines for the management and treatment of morbidly obese patients. J Endocrinol Invest. 2007 Nov;30(10):844-52.

Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. Review.

Witt N, Wong TY, Hughes AD, Chaturvedi N, Klein BE, Evans R, McNamara M, Thom SA, Klein R. Abnormalities of retinal microvascular structure and risk of mortality from ischemic heart disease and stroke. Hypertension. 2006 May;47(5):975-81. Epub 2006 Apr 3.

Stein JH, Korcarz CE, Hurst RT, Lonn E, Kendall CB, Mohler ER, Najjar SS, Rembold CM, Post WS; American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Use of carotid ultrasound to identify subclinical vascular disease and evaluate cardiovascular disease risk: a consensus statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr. 2008 Feb;21(2):93-111; quiz 189-90. Review. No abstract available. Erratum in: J Am Soc Echocardiogr. 2008 Apr;21(4):376.

Blum M, Bachmann K, Pietscher S, Bräuer-Burchardt C, Vilser W, Strobel J. [Online measurement of retinal artery branches in type II diabetic patients. Initial clinical trials before and after laser coagulation] Ophthalmologe. 1997 Oct;94(10):724-7. German.

Blum M, Bachmann K, Wintzer D, Riemer T, Vilser W, Strobel J. Noninvasive measurement of the Bayliss effect in retinal autoregulation. Graefes Arch Clin Exp Ophthalmol. 1999 Apr;237(4):296-300.

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 University Hospital 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 May 16, 2013

Mannheim Obesity Study (MOS)