OBESITY, METABOLISM

CRS guides your metabolic research to success

The fatal consequences of metabolic disorders

The sequence of overweight, obesity, insulin resistance, inflammation, and diabetes mellitus is a driver in cardiovascular morbidity and mortality. In 2014 nearly 2 billion adults were considered overweight and more than 600 million were found obese presenting with a Body-Mass-Index (BMI) > 30 kg/m². Decreasing physical activity, sedentary lifestyle, unhealthy food consumption, stress, and a low socioeconomic status were identified as the main components associated with obesity and the metabolic syndrome.

In fact, obesity and the metabolic syndrome cause an increase in intraabdominal visceral fat mass and especially the accumulation of ectopic and perivascular fat in organs such as liver, skeletal muscle, heart, and the kidney. This in turn is predictive of comorbidities such as diabetes mellitus, non-alcoholic steatohepatitis (NASH), cardiovascular or renal complications.

Furthermore, numerous cytokines released from visceral adipocytes trigger inflammation, lipid disorders, an increase in blood pressure, and an augmented insulin sensitivity. All together accelerate an increase in all-cause mortality, as well as an increase in cardiovascular disease, heart failure, or cancer.

CRS‘ outstanding experience in clinical research of metabolic disorders

CRS has outstanding experience in clinical research on all these factors and in conducting proof of concept studies addressing measures of food consumption, energy metabolism, insulin resistance, and adipose tissue dysfunction. To this end, CRS employs the following testing procedures:

Food Consumption

• Standardized Meal Tests
• Quantification of Ad Libitum Food Uptake Tests
• Assessment of hunger, satiety, fullness and prospective food with questionnaires
  • Consumption questionnaires
  • Controlled Eating Questionnaire (CoEaQ)
  • Assessment of caloric intake by food diaries

Insulin Resistance

• HOMAIR; Quicki Index
• Standardized test meals
• Oral Glucose Tolerance Test (OGTT)
• Intravenous Glucose Tolerance Test (IVGTT)
• Euglycemic Glucose Clamp Tests (M-value)

Fat Tissue Assessment

• Body Impedance Measurement
• Subcutaneous Fat Biopsies
• Liver Fat Content (Fibro Scan®, MRI-PDFF)

Biomarker

• Adipokines
  • Adiponectin
  • Leptin
  • Visfatin
  • Resistin
  • …

• Cytokines
  • TNF-alpha
  • Interleukin-6 (IL-6)
  • Interleukin-1ß (IL-1ß)
  • …

CRS bridging preclinical evidence to proof-of-concept for new metabolically active therapies

The constant care of a powerful CRS proprietary database of volunteers and patients together with a solid network of collaborating medical specialists and office-based family doctors are the key to our highly effective recruitment of healthy volunteers or obese subjects.

CRS-owned excellent equipped and carefully quality controlled Early Phase Clinical Trial Units are a reliable guarantee for CRS-customers for a conduct of the trial according to all regulatory requirements of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Together with carefully selected external clinical centers of excellence we at CRS can provide a wide range of studies bridging from preclinical evidence to the proof of concept in healthy humans or obese subjects.

CRS’ experienced scientists, statisticians and medical writers can provide essential support in the creating powerful study outlines or writing the study protocols in preparation of a study, as well as in finalizing study reports and drafting manuscripts for publication in scientific journals after completion of the clinical trial.
A large number of scientific papers published in international peer-reviewed journals are proof of our outstanding expertise in this therapeutic area.

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