Routine assessments in clinical trials
At Profil, a variety of diagnostic methods have been established as standards for the assessment and monitoring of diabetes-related issues such as cardiovascular complications and microvascular complications such as diabetic nephropathy or diabetic retinopathy.
Routine tests of renal function include assessments of eGFR, albuminuria and cystatine C, ultrasound imaging and GFR determination via iohexole clearance.
Retinopathy is regularly assessed using mydriatic and non-mydriatic ophthalmoscopy and fundus photography at our institute or in collaboration with registered local ophthalmologists.
Clinical and technical assessments for the diagnosis of diabetic neuropathy are done in accordance with international guidelines, and include standard quantitative sensory testing and the use of challenge tests (e.g., the Ewing battery) for cardiovascular autonomic testing, orthostatic regulation of blood pressure, baroreflex sensitivity, and spectral analysis of the heart rate. Delayed gastric emptying can be assessed by tests such as the octanoate breath test and measurement of oral glucose absorption with stable isotopes.
Non-invasive methods are available for the study of a range of relevant vascular responses, such as possible treatment effects on microvascular and macrovascular function.
Vascular ultrasound is used to measure intima media thickness or flow-mediated dilation to assess the endothelial function of essential vessels, such as of the brachial artery.
Microvascular function tests include laser Doppler methods. Neurovascular and endothelial regulatory mechanisms can be studied using a battery of functional tests, including standard provocation tests, such as heat, iontophoresis, ischemia, and sympathetic activation by the cold–pressure test or deep breath test.
The importance of monitoring diabetes complications
The management of cardiovascular disease, microvascular complications and other diabetes-related issues is pivotal in the diagnostic and therapeutic approach to individuals with diabetes mellitus.
The increased risk for cardiovascular disease (CVD) is a major contributor to the excessive mortality and morbidity in patients with diabetes. CVD is responsible for more than half of all deaths among people with diabetes, and mortality from CVD is almost 2-fold higher in diabetes patients than in people without diabetes.
Microvascular complications of diabetes are among the leading causes of blindness, end-stage kidney failure and lower limb amputation in Western countries. They are accompanied by a markedly increased mortality and risk for cardiovascular events.
Preventing diabetes complications, mitigating their consequences and possibly reversing them is not just one of the primary objectives of patient care but also a major goal for clinical research.
Regulatory requirements for monitoring diabetes complications
Microvascular comorbidity can alter the pharmacokinetic characteristics of a drug due to impaired renal function or delayed gastric emptying. EMA and FDA guidelines therefore require that developers of novel treatments perform and submit studies involving specific target populations with such diabetes complications.
Recruitment to clinical studies of diabetes complications
Successful clinical research in the field of diabetes complications depends on the smooth recruitment of specific study populations, including patients with cardiovascular disease, neuropathy, retinopathy and different stages of diabetic kidney disease. The common presence of comorbidity may further restrain the inclusion of patients, and a successful and swift recruitment relies on a large database of diabetes patients, but also on close cooperation with local diabetologists, ophthalmologists, cardiologists and nephrologists.
Profil Germany: a partner for studies of diabetes complications
Besides the range of diagnostic methods established as standards for the monitoring and assessment of the complex complications associated with diabetes and obesity, Profil Germany has both an extensive database of suitable candidates for a variety of clinical studies and a network of physicians in the appropriate fields of medicine. This makes us an ideal partner for clinical diabetic retinopathy research, diabetic nephropathy research, cardiometabolic research and other conditions.