ObesityMOSNCT00770276
Mannheim Obesity Study
An observational study of Obesity, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Obesity
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient department of an university hospital
Who may be able to join
- obesity WHO I-III
Who cannot join
- pregnancy
- acute vascular event within the last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital of Mannheim
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity
MOPS: Mannheim Obesity Pilot Study
Introduction:
Read more
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).
Read the detailed description
Methods and procedures
Study design:
We conducted a prospective study in obesity WHO III° with consecutive enrollment. The study protocol was approved by the local ethics committee. Patients were recruited within an integrated concept designed for individuals seeking weight reduction. This network encompassed a complex approach by nutrition specialists, bariatric surgeons, endocrinologists, ENT specialists and psychologists. Patients could present themselves at any of the aforementioned specialists for study inclusion. Those who consented were followed, after conventional weight loss (diet, activity) or bariatric surgery 1 year later.
Evaluation:
Using a standardized form, we evaluated the medical and obesity history as well as associated metabolic complications (impaired glucose metabolism, elevated Cholesterol and NASH). We further inquired about regular medication, related diseases and classic cardiovascular risk factors (Framingham risk score: cardiovascular disease, family history of cardiovascular disease, nicotine abuse and arterial hypertension).
Anthropometry - Subsequently, a complete physical examination was conducted, taking into consideration the use of an adequate cuff to measure blood pressure. We further recorded circumferences of the neck, arm and waist (midway between the lower rib margin and iliac crest, with a measuring tape at the end of gentle expiration). Body weight and height were determined by calibrated scales to the nearest 0.1kg and cm, respectively.
Metabolism - Metabolic analysis was performed after an overnight fast. Baseline measurements included blood glucose, insulin, cholesterol, HDL, LDL, triglycerides and liver enzymes. Every individual without known diabetes was screened for the presence of impaired glucose metabolism by means of an OGTT. To exclude endocrine obesity we measured TSH levels and performed a one mg dexamethasone suppression test.
Intima media thickness (IMT) - Measurement of the intima media thickness of the right carotid artery was performed in order to detect subclinical vascular disease. Imaging protocol was executed according to the consensus statement of the American Society of Echocardiography (5).
Structural and functional endothelial dysfunction: Arterial and venous ratio (AVR) and flicker reaction - DVA was used for digital fundus imaging as well as conventional fundus examinations and retinal vessel analysis (RVA, imedos, Jena, Germany). Structural endothelial dysfunction was determined by arterial-venous ratio (AVR). After mydriasis with phenylephrine 10% and tropicamide 1%, images centred on the macula, the inferior arcade and the optic disc were recorded in both eyes. AVR was calculated by software after marking arteries and veins within two diameters of the optic disc (RVA, imedos, Jena, Germany).
Functional endothelial dysfunction was measured by flicker reaction of retinal vessels. This technique records dilatation of retinal vessels during and after exposure to flickering light. We used 1.5 mm segments of vessels within two disc diameters, which showed no crossing or bifurcation, and had a tortuosity < 30°. After baseline calibration, flickering light was shown for 20 seconds via interruption of continuous light at 12.5 Hz. During this period and for further 80 seconds, vessel diameter was continuously measured. To achieve higher reliability, this procedure was performed three times. Flicker of the artery and vein was expressed as the maximum in percent of the baseline diameter. Adjustment for eye movement was performed automatically by software. Details of this technique were published elsewhere (6-7).
BIA - Body composition was determined preoperatively by BIA. All patients were required to rest for 30 minutes, after which BIA was performed by applying 4 silver electrodes, with 2 detecting electrodes placed at the ulnar aspect of the right wrist and the right medial malleolus. After connecting the electrodes to the multiple-frequency BIA instrument (BIA 2000, Data Input, Darmstadt, Germany), measurements were recorded in real time via computer. The calculations for BCM, ECM, ECM/BCM, fat and TBW were performed using Nutri 2000 software (Data Input, Darmstadt, Germany).
Endpoints - The endpoint of our study was the identification of cardiovascular risk and metabolic complications or factors representing these risks in a population with obesity WHO. Therefore, we measured parameters of the metabolic syndrome, endothelial dysfunction and subclinical atherosclerosis. Patients, who gave informed consent, are followed after conventional weight loss (diet, activity) or bariatric surgery yearly. The decision for the type of intervention is connected to a complex process. According to the German obesity society subjects with more than 40 kg/m2 and patients with a BMI > 35 kg/m2 with obesity associated disease have the indication for bariatric surgery. After drafting of an expert's opinion for coverage of the costs by the health insurance patients may attend bariatric surgery. Because of the noncommittal character of the guideline of the German obesity society to health insurances not all patients will be able to get coverage for their surgery costs. Patients who are not able to get cost coverage or refuse surgery represent the conservative treatment (activity, diet). The interventional group will be treated by bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass). Therefore, the study has observational character.
- Conditions
- Obesity
- Keywords
- obesity WHO I-III, metabolic syndrome, Framingham risk score, subclinical atherosclerosis, endothelial dysfunction
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Bariatric surgery | |
| conservative Therapie | diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome
Measured: baseline, after 1 and 2 years
Framingham risk score
Measured: baseline, 1 and 2 years
Subclinical atherosclerosis (IMT)
Measured: baseline, 1 and 2 years
Endothelial dysfunction
Measured: baseline, 1 and 2 years
Secondary outcomes (1)
Change in body weight
Measured: baseline, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJan 2005
- Primary completionFeb 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Lammert, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770276
- Sponsor's protocol ID
- MOS
- Acronym
- MOS
- Status last verified
- Jan 2018
- First submitted
- 8 Oct 2008
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10511607Burguera 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.
PubMed 18075287Davignon 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.
PubMed 15198963Witt 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.
PubMed 16585415Stein 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.
PubMed 18261694Blum 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.
PubMed 9432241Blum 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.
PubMed 10208262Lammert 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.
PubMed 22555362Lammert 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.
PubMed 23009954Mattern 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.
PubMed 28314833Lammert 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.
PubMed 26948683Bachmayer 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.
PubMed 23765752
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity
- ClinicalTrials.gov ID
- NCT00770276
- Acronym / sponsor ID
- MOS / MOS
- Conditions
- Obesity
- Keywords
- obesity WHO I-III, metabolic syndrome, Framingham risk score, subclinical atherosclerosis, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Methods and procedures
Study design:
We conducted a prospective study in obesity WHO III° with consecutive enrollment. The study protocol was approved by the local ethics committee. Patients were recruited within an integrated concept designed for individuals seeking weight reduction. This network encompassed a complex approach by nutrition specialists, bariatric surgeons, endocrinologists, ENT specialists and psychologists. Patients could present themselves at any of the aforementioned specialists for study inclusion. Those who consented were followed, after conventional weight loss (diet, activity) or bariatric surgery 1 year later.
Evaluation:
Using a standardized form, we evaluated the medical and obesity history as well as associated metabolic complications (impaired glucose metabolism, elevated Cholesterol and NASH). We further inquired about regular medication, related diseases and classic cardiovascular risk factors (Framingham risk score: cardiovascular disease, family history of cardiovascular disease, nicotine abuse and arterial hypertension).
Anthropometry - Subsequently, a complete physical examination was conducted, taking into consideration the use of an adequate cuff to measure blood pressure. We further recorded circumferences of the neck, arm and waist (midway between the lower rib margin and iliac crest, with a measuring tape at the end of gentle expiration). Body weight and height were determined by calibrated scales to the nearest 0.1kg and cm, respectively.
Metabolism - Metabolic analysis was performed after an overnight fast. Baseline measurements included blood glucose, insulin, cholesterol, HDL, LDL, triglycerides and liver enzymes. Every individual without known diabetes was screened for the presence of impaired glucose metabolism by means of an OGTT. To exclude endocrine obesity we measured TSH levels and performed a one mg dexamethasone suppression test.
Intima media thickness (IMT) - Measurement of the intima media thickness of the right carotid artery was performed in order to detect subclinical vascular disease. Imaging protocol was executed according to the consensus statement of the American Society of Echocardiography (5).
Structural and functional endothelial dysfunction: Arterial and venous ratio (AVR) and flicker reaction - DVA was used for digital fundus imaging as well as conventional fundus examinations and retinal vessel analysis (RVA, imedos, Jena, Germany). Structural endothelial dysfunction was determined by arterial-venous ratio (AVR). After mydriasis with phenylephrine 10% and tropicamide 1%, images centred on the macula, the inferior arcade and the optic disc were recorded in both eyes. AVR was calculated by software after marking arteries and veins within two diameters of the optic disc (RVA, imedos, Jena, Germany).
Functional endothelial dysfunction was measured by flicker reaction of retinal vessels. This technique records dilatation of retinal vessels during and after exposure to flickering light. We used 1.5 mm segments of vessels within two disc diameters, which showed no crossing or bifurcation, and had a tortuosity < 30°. After baseline calibration, flickering light was shown for 20 seconds via interruption of continuous light at 12.5 Hz. During this period and for further 80 seconds, vessel diameter was continuously measured. To achieve higher reliability, this procedure was performed three times. Flicker of the artery and vein was expressed as the maximum in percent of the baseline diameter. Adjustment for eye movement was performed automatically by software. Details of this technique were published elsewhere (6-7).
BIA - Body composition was determined preoperatively by BIA. All patients were required to rest for 30 minutes, after which BIA was performed by applying 4 silver electrodes, with 2 detecting electrodes placed at the ulnar aspect of the right wrist and the right medial malleolus. After connecting the electrodes to the multiple-frequency BIA instrument (BIA 2000, Data Input, Darmstadt, Germany), measurements were recorded in real time via computer. The calculations for BCM, ECM, ECM/BCM, fat and TBW were performed using Nutri 2000 software (Data Input, Darmstadt, Germany).
Endpoints - The endpoint of our study was the identification of cardiovascular risk and metabolic complications or factors representing these risks in a population with obesity WHO. Therefore, we measured parameters of the metabolic syndrome, endothelial dysfunction and subclinical atherosclerosis. Patients, who gave informed consent, are followed after conventional weight loss (diet, activity) or bariatric surgery yearly. The decision for the type of intervention is connected to a complex process. According to the German obesity society subjects with more than 40 kg/m2 and patients with a BMI > 35 kg/m2 with obesity associated disease have the indication for bariatric surgery. After drafting of an expert's opinion for coverage of the costs by the health insurance patients may attend bariatric surgery. Because of the noncommittal character of the guideline of the German obesity society to health insurances not all patients will be able to get coverage for their surgery costs. Patients who are not able to get cost coverage or refuse surgery represent the conservative treatment (activity, diet). The interventional group will be treated by bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass). Therefore, the study has observational character.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | –Bariatric surgery |
| conservative Therapie | – | –diet and exercise |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient department of an university hospital
Key inclusion criteria (1 listed)
- obesity WHO I-III
Key exclusion criteria (2 listed)
- pregnancy
- acute vascular event within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic syndrome
Time frame: baseline, after 1 and 2 years
Framingham risk score
Time frame: baseline, 1 and 2 years
Subclinical atherosclerosis (IMT)
Time frame: baseline, 1 and 2 years
Endothelial dysfunction
Time frame: baseline, 1 and 2 years
1 secondary outcome
Change in body weight
Time frame: baseline, 1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Background: PubMed 10511607Calle 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.
- Background: PubMed 18075287Burguera 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.
- Background: PubMed 15198963Davignon 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.
- Background: PubMed 16585415Witt 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.
- Background: PubMed 18261694Stein 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.
- Background: PubMed 9432241Blum 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.
- Background: PubMed 10208262Blum 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.
- Results publication: PubMed 22555362Lammert 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.
- Results publication: PubMed 23009954Lammert 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.
- Derived from this study: PubMed 28314833Mattern 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.
- Derived from this study: PubMed 26948683Lammert 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.
- Derived from this study: PubMed 23765752Bachmayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome (time frame: baseline, after 1 and 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770276, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.