--- title: "Complications in diabetes: a speciality for Profil" description: Profil has established a variety of methods for assessing diabetes-related issues such as diabetic retinopathy and cardiovascular complications. --- [![profil-logo-wortbild-with claim-4c-offset_1000px](https://www.profil.com/hs-fs/hubfs/profil-logo-wortbild-with%20claim-4c-offset_1000px.png?width=250&name=profil-logo-wortbild-with%20claim-4c-offset_1000px.png "profil-logo-wortbild-with claim-4c-offset_1000px")](https://www.profil.com?hsLang=en-us) [![Contact](https://no-cache.hubspot.com/cta/default/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/1f89c7d1-107f-4c8d-aa7b-f85d0dce14da) [Patient information](https://www.profil.de) # [![Diabetes Complications](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/Header/Header_1077x260px_Diabetes_Treatment.jpg?width=1077&height=260&name=Header_1077x260px_Diabetes_Treatment.jpg) Diabetes Complications Learn about our diagnostic methods to assess and monitor diabetes complications.](https://www.profil.com/expertise/cardiovascular-complications#) ## Routine assessment of diabetes complication status 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 aceteminophen absorption. 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: 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 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. ![pikto2.png](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_NewWebinar.png?width=62&height=70&name=Icon_NewWebinar.png) ### Free  Consultation Are you planning a study? Make sure to request your free project consultation now. [![Request now](https://no-cache.hubspot.com/cta/default/481167/3e4e3d1f-5461-4cd2-84e5-24cfae3c671e.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/3e4e3d1f-5461-4cd2-84e5-24cfae3c671e) ![Tim_Hexagon_154x176](https://www.profil.com/hs-fs/hubfs/Mitarbeiter/Tim_Hexagon_154x176.png?width=154&height=175&name=Tim_Hexagon_154x176.png) ### Our expert **Dr. Tim Heise** Lead Scientist [![Contact](https://no-cache.hubspot.com/cta/default/481167/96e42971-e647-4df5-9207-76510d17c7d1.png)](https://cta-redirect.hubspot.com/cta/redirect/481167/96e42971-e647-4df5-9207-76510d17c7d1) ![Complications](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/content-bilder/Diabetes_Complications/Diabetes-Complications_Content1.png?width=470&height=220&name=Diabetes-Complications_Content1.png) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_References.png?width=49&height=49&name=Icon_References.png) #### References We have published with the following sponsors: ![Referenzen](https://www.profil.com/hubfs/BLUE_MOON/content-bilder/Referenzen.gif "Referenzen") [View more](https://www.profil.com/knowledge-center/references?hsLang=en-us) ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Certificates.png?width=44&height=49&name=Icon_Certificates.png) #### Certificates | ![13485_Zertifikatssiegel_black_A3](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_134852016_certificate_blue.png) ISO 13485:2016 ![27001_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_27001_certificate_.png) ISO 27001 | ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/ISO_9001-2015_certificate.png) ISO 9001:2015 ![9001:2015_Zertifikatssiegel](https://www.profil.com/hubfs/BLUE_MOON/piktos/BVMA_Logo_Certificate_size.png) BVMA Member | | --- | --- | ![blank.jpg](https://www.profil.com/hs-fs/hubfs/BLUE_MOON/piktos/Icon_Publications.png?width=44&height=49&name=Icon_Publications.png) #### Publications Herbrand, T. et al. 2020. Improving the Assessment of Flow-Mediated Dilation Through Detection of Peak Time in Healthy Subjects and Subjects With Type 2 Diabetes. Angiology. 2020 Dec 30;3319720984884. [View all](https://www.profil.com/knowledge-center/publications?hsLang=en-us) Because Profil Germany is a full-service diabetes-focused CRO, diabetes complications are one of our major areas of expertise. Profil recognizes the importance of routine assessments for cardiovascular complications and various other microvascular complications during clinical trials. We contribute to important diabetes-related research, including diabetic retinopathy research, diabetic nephropathy research and cardiometabolic research. ###### Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9 · 41460 - Neuss, Germany Telefon +49-2131-4018-345 · marketing@profil.com [Imprint](https://www.profil.com/imprint?hsLang=en-us) | [Privacy Policy](https://www.profil.com/privacy?hsLang=en-us)