"Early phase obesity research & how to measure outcomes of interest"
Insights from Dr. Daniela Lamers, Nutritional Science Specialist at Profil:
You will benefit by learning about:
- Obesity facts / background: Present situation and estimates for the future
- Current trends in obesity research: New drug development / other strategies for weight loss, Cadiovascular outcome studies
- Planning an obesity trial - Which endpoints / outcomes should I measure? Body composition measures, Metabolic balances: Measuring energy intake and energy expenditure, Measuring other metabolic risk factors
It is well known that obesity and overweight are highly contributing to a marked increase in type 2 diabetes. However, despite increasing obesity rates, the number of new diabetes cases seems to decline - this is the outcome of a report published in May this year, analysing new federal data of U.S. adults. According to these studies 1.3 million new diabetes diagnoses were made in 2017, compared to 1.7 million in 2009. After an almost 20-year increase in the national prevalence and incidence of diagnosed diabetes cases (1990-2009), an 8-year period of stable prevalence and a decrease in incidence has occurred.
Even though the underlying mechanics for this phenomenon are not fully understood, one important contributing factor is thought to be increasing efforts to identify and treat overweight and obese individuals at high metabolic risk (prediabetes).Although so-called lifestyle changes - comprising diet and an increase in physical activity - are still the first line approach, the past years have seen approval of quite a few novel anti-obesity drugs. The majority of these influence hypothalamic appetite pathways via dopaminergic or serotoninergic signalling or mimic endogenous satiety signals using long-lasting forms of peripheral appetite suppressing hormones. There is also considerable interest in targeting thermogenesis by brown adipose tissue to increase resting energy expenditure. Obesity pharmacotherapy has seen several false dawns, but improved understanding of the pathways regulating energy balance, and better-designed trials give greater confidence that recently approved agents will be both efficacious and safe.
Hence, understanding the energy equation in terms of energy intake and energy expenditure is imperative for any given weight loss intervention. Profil’s metabolic ward is specialized in meeting nutritional requirements in clinical research. Our metabolic kitchen allows the investigation and control of the impact of nutritional conditions in clinical trials. To date, Profil has performed more than 70 studies with standardized nutritional regimens helping to match nutritional plans to the objectives of any trial, for example when mixed meal tolerance tests or individual diets are needed.
On the other side of the scale, also energy expenditure requires sophisticated methodology. Depending on the study design, total energy requirements can be determined based on resting metabolic rate, measured via indirect calorimetry or estimated with commonly used formulas using individual anthropometric measurements including body composition. In addition to resting energy expenditure, nutrient-induced thermogenesis and exercise-induced thermogenesis can be assessed via indirect calorimetry as contributing variables to total energy expenditure.
In addition, Profil provides the possibility to assess other outcome variables. The “classical” anthropometric parameters such as BMI and waist circumference can be extended to precise body composition measurements in terms fat and fat-free mass with the help of densitometry – air displacement plethysmography (BOD POD®). Recent evidence indicates an increase of liver fat as being another key factor predisposing obese people to the development of insulin resistance. Profil provides the measurement of liver fat directly using magnetic resonance spectroscopy (MRS) or indirectly using the fatty liver index (FLI), which is a composite surrogate of gamma-glutamyltransferase, triglycerides, waist circumference and BMI. Insulin resistance (IR) is a classical feature of prediabetes. It may be present years before deterioration in blood glucose control becomes measurable. In this regard, Profil uses the most accurate and reliable measure of insulin sensitivity: the hyperinsulinemic euglycemic clamp technique.
The experience and methodology at Profil's disposal, makes us experts in the area. Join this webinar to get an overview of current trends in obesity research and available technologies and learn in detail about study designs in clinical trials.
Meet the presenter
Dr. Daniela Lamers is Nutritional Science Specialist at Profil.
Daniela is a biologist and Nutritional Science Specialist at Profil. She has an academic background in basic science with special focus on molecular biology. During her PhD thesis at the German Diabetes Center in Düsseldorf she identified novel adipocyte-secreted factors and investigated their impact on the development of insulin resistance in various cell culture models.
She joined Profil in 2012 being part of the clinical operations unit. Since 2015 she is working in the Project Development team. Her particular interests are methods for the assessment of energy metabolism, including indirect calorimetry for the measurement of resting and diet-induced energy expenditure and the doubly labelled water method for the measurement of "free-living" total energy expenditure.
Trained in EU food law she is Profil’s expert to consult you on the best study design for your health claims study.