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Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity

18 Years
88 Years
Open (Enrolling)

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Trial Information

Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity

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.


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.

Inclusion Criteria:

- obesity WHO I-III

Exclusion Criteria:

- pregnancy

- acute vascular event within the last 3 months

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Metabolic syndrome

Outcome Time Frame:

baseline, after 1 and 2 years

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2005

Completion Date:

January 2017

Related Keywords:

  • Obesity
  • obesity WHO I-III
  • metabolic syndrome
  • Framingham risk score
  • subclinical atherosclerosis
  • endothelial dysfunction
  • Obesity