NCT00770276

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

13.1 years

First QC Date

October 8, 2008

Last Update Submit

January 2, 2018

Conditions

Obesity

Keywords

obesity WHO I-IIImetabolic syndromeFramingham risk scoresubclinical atherosclerosisendothelial dysfunction

Outcome Measures

Primary Outcomes (4)

  • Metabolic syndrome

    baseline, after 1 and 2 years

  • Framingham risk score

    baseline, 1 and 2 years

  • Subclinical atherosclerosis (IMT)

    baseline, 1 and 2 years

  • Endothelial dysfunction

    baseline, 1 and 2 years

Secondary Outcomes (1)

  • Change in body weight

    baseline, 1 and 2 years

Study Arms (2)

Bariatric surgery

Bariatric surgery

conservative Therapie

diet and exercise

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient department of an university hospital

You may qualify if:

  • obesity WHO I-III

You may not qualify if:

  • pregnancy
  • acute vascular event within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (12)

  • 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. doi: 10.1056/NEJM199910073411501.

    PMID: 10511607BACKGROUND

  • 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, Moize V, Moreno B, Moreiro J, Ricart W, Riesco M, Salinas R, Salvador J, Pi-Sunyer FX, Scopinaro N, Sjostrom L, Pagan A, Pereg V, Sanchez 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. doi: 10.1007/BF03349226.

    PMID: 18075287BACKGROUND

  • Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.

    PMID: 15198963BACKGROUND

  • 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. doi: 10.1161/01.HYP.0000216717.72048.6c. Epub 2006 Apr 3.

    PMID: 16585415BACKGROUND

  • 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. doi: 10.1016/j.echo.2007.11.011. No abstract available.

    PMID: 18261694BACKGROUND

  • Blum M, Bachmann K, Pietscher S, Brauer-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. doi: 10.1007/s003470050193. German.

    PMID: 9432241BACKGROUND

  • 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. doi: 10.1007/s004170050236.

    PMID: 10208262BACKGROUND

  • Lammert A, Hasenberg T, Kraupner C, Schnulle 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.

    PMID: 22555362RESULT

  • Lammert A, Hasenberg T, Imhof I, Schnulle P, Benck U, Kramer 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.

    PMID: 23009954RESULT

  • Mattern J, Lammert A, Otto M, Hammes HP. Retinopathy in an obesity WHO III cohort: prevalence and risk factors. Br J Ophthalmol. 2017 Nov;101(11):1550-1554. doi: 10.1136/bjophthalmol-2016-309566. Epub 2017 Mar 17.

    PMID: 28314833DERIVED

  • Lammert A, Nittka S, Otto M, Schneider-Lindner V, Kemmer A, Kramer BK, Birck R, Hammes HP, Benck U. Performance of the 1 mg dexamethasone suppression test in patients with severe obesity. Obesity (Silver Spring). 2016 Apr;24(4):850-5. doi: 10.1002/oby.21442. Epub 2016 Mar 7.

    PMID: 26948683DERIVED

  • Bachmayer C, Lammert A, Hasenberg T, Hammes HP. Healthy obese and post bariatric patients - metabolic and vascular patterns. Exp Clin Endocrinol Diabetes. 2013 Aug;121(8):483-7. doi: 10.1055/s-0033-1347248. Epub 2013 Jun 13.

    PMID: 23765752DERIVED

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

January 1, 2005

Primary Completion

February 1, 2018

Study Completion

January 1, 2020

Last Updated

January 4, 2018

Record last verified: 2018-01

Locations

DE(1)