The TUDID Study – Background and Design of a Prospective Cohort

Abstract

Prevalence of both type 1 and type 2 diabetes mellitus is growing worldwide and one major cause for morbidity and mortality. However, not every patient develops diabetes-related complications, but causes for the individual susceptibility are still not fully understood. As a platform to address this, we initiated the TUDID (TUebingen DIabetes Database) study, a prospective, monocentric, observational study that includes adults with diabetes mellitus who are treated in the inpatient clinic of a University Hospital in southern Germany. Besides a thorough clinical examination and extensive laboratory tests (with integrated biobanking), major study focuses are the kidneys, the eyes, the vasculature as well as cognition and mood where standardized investigations for early stages for diabetes complications are performed. Analyses of the data generated by this precise characterization of diabetes-related complications will contribute to our understanding of the development and course of such complications, and thus facilitate the implementation of tailored treatment options that can reduce the risk and severity of diabetes-related complications.

Key words

diabetes complications - observational - prospective

Publication History

Received: 15 May 2020
Received: 03 July 2020

Accepted: 17 July 2020

Article published online:
10 September 2020

• References

• 1 Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol 2018; 14: 88-98
• 2 Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther 2008; 88: 1254-1264
• 3 Steffes MW, Sibley S, Jackson M. et al. β-cell function and the development of diabetes-related complications in the diabetes control and complications trial. Diabetes Care 2003; 26: 832-836
• 4 Said G. Diabetic neuropathy—a review. Nat Rev Neurol 2007; 3: 331-340
• 5 Davies M, Brophy S, Williams R. et al. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care 2006; 29: 1518-1522
• 6 Pop-Busui R, Boulton AJM, Feldman EL. et al. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care 2017; 40: 136-154
• 7 Dronavalli S, Duka I, Bakris GL. The pathogenesis of diabetic nephropathy. Nat Rev Endocrinol 2008; 4: 444-452
• 8 Tuttle KR, Bakris GL, Bilous RW. et al. Diabetic Kidney Disease: A Report From an ADA Consensus Conference. Diabetes Care 2014; 37: 2864-2883
• 9 Yau JWY, Rogers SL, Kawasaki R. et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy. Diabetes Care 2012; 35: 556-564
• 10 Ting DSW, Cheung GCM, Wong TY. Diabetic retinopathy: Global prevalence, major risk factors, screening practices and public health challenges: a review. Clin Experiment Ophthalmol 2016; 44: 260-277
• 11 Thomas RL, Dunstan FD, Luzio SD. et al. Prevalence of diabetic retinopathy within a national diabetic retinopathy screening service. Br J Ophthalmol 2015; 99: 64-68
• 12 Jampol LM, Glassman AR, Sun J. Evaluation and care of patients with diabetic retinopathy. N Engl J Med 2020; 382: 1629-1637
• 13 Xie J, Ikram MK, Cotch MF. et al. Association of Diabetic Macular Edema and Proliferative Diabetic Retinopathy With Cardiovascular Disease: A systematic review and meta-analysis. JAMA Ophthalmol 2017; 135: 586-593
• 14 Weitz Jeffrey I, John Byrne, Patrick ClagettG.. et al. Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A Critical Review. Circulation 1996; 94: 3026-3049
• 15 Marso SP, Hiatt WR. Peripheral Arterial Disease in Patients With Diabetes. J Am Coll Cardiol 2006; 47: 921-929
• 16 Hobizal KB, Wukich DK. Diabetic foot infections: Current concept review. Diabet Foot Ankle 2012; 3
• 17 Koekkoek PS, Kappelle LJ, van den Berg E. et al. Cognitive function in patients with diabetes mellitus: Guidance for daily care. Lancet Neurol 2015; 14: 329-340
• 18 Hazari MAH, Ram Reddy B, Uzma N. et al. Cognitive impairment in type 2 diabetes mellitus. Int J Diabetes Mellit 2015; 3: 19-24
• 19 Kullmann S, Heni M, Veit R. et al. Selective insulin resistance in homeostatic and cognitive control brain areas in overweight and obese adults. Diabetes Care 2015; 38: 1044-1050
• 20 Nunley KA, Rosano C, Ryan CM. et al. Clinically relevant cognitive impairment in middle-aged adults with childhood-onset type 1 diabetes. Diabetes Care 2015; 38: 1768-1776
• 21 Luchsinger JA, Reitz C, Patel B. et al. Relation of Diabetes to Mild Cognitive Impairment. Arch Neurol 2007; 64: 570-575
• 22 Anderson RJ, Freedland KE, Clouse RE. et al. The Prevalence of Comorbid Depression in Adults With Diabetes: A meta-analysis. Diabetes Care 2001; 24: 1069-1078
• 23 Darwish L, Beroncal E, Sison MV. et al. Depression in people with type 2 diabetes: Current perspectives. Diabetes Metab Syndr Obes Targets Ther 2018; 11: 333-343
• 24 Sanz M, Ceriello A, Buysschaert M. et al. Scientific evidence on the links between periodontal diseases and diabetes: Consensus report and guidelines of the joint workshop on periodontal diseases and diabetes by the International Diabetes Federation and the European Federation of Periodontology. J Clin Periodontol 2018; 45: 138-149
• 25 Löe H. Periodontal Disease: The sixth complication of diabetes mellitus. Diabetes Care 1993; 16: 329-334
• 26 Graves DT, Ding Z, Yang Y. The impact of diabetes on periodontal diseases. Periodontol 2000 2020; 82: 214-224
• 27 Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol 2016; 4: 537-547
• 28 Fowler MJ. Microvascular and Macrovascular Complications of Diabetes. Clin Diabetes 2008; 26: 77-82
• 29 Bommer C, Sagalova V, Heesemann E. et al. Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030. Diabetes Care 2018; 41: 963-970
• 30 Association AD. 2 Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2018. Diabetes Care 2018; 41: S13-S27.
• 31 Feldman EL, Stevens MJ, Thomas PK. et al. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994; 17: 1281-1289
• 32 Herman WH, Pop-Busui R, Braffett BH. et al. Use of the Michigan Neuropathy Screening Instrument as a measure of distal symmetrical peripheral neuropathy in Type 1 diabetes: Results from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications. Diabet Med J Br Diabet Assoc 2012; 29: 937-944
• 33 Moghtaderi A, Bakhshipour A, Rashidi H. Validation of Michigan neuropathy screening instrument for diabetic peripheral neuropathy. Clin Neurol Neurosurg 2006; 108: 477-481
• 34 Ling CHY, de Craen AJM, Slagboom PE. et al. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr 2011; 30: 610-615
• 35 Xu D, Zou L, Xing Y. et al. Diagnostic Value of ankle-brachial index in peripheral arterial disease: A meta-analysis. Can J Cardiol 2013; 29: 492-498
• 36 Victor Aboyans, Criqui Michael H, Pierre Abraham. et al. Measurement and interpretation of the ankle-brachial index. Circulation 2012; 126: 2890-2909
• 37 Petersen C, Peçanha PB, Venneri L. et al. The impact of carotid plaque presence and morphology on mortality outcome in cardiological patients. Cardiovasc Ultrasound 2006; 4: 16-16
• 38 Nathan DM. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study at 30 Years: Overview. Diabetes Care 2014; 37: 9-16
• 39 Holle R, Happich M, Löwel H. et al. KORA - A Research Platform for Population Based Health Research. Gesundheitswesen 2005; 67: 19-25
• 40 Riboli E, Kaaks R. The EPIC Project: Rationale and study design. European Prospective Investigation into Cancer and Nutrition. Int J Epidemiol 1997; 26 Suppl 1 S6-14
• 41 Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet 1998; 352: 837-853
• 42 Effects of Intensive Glucose Lowering in Type 2 Diabetes N Engl J Med 2008; 358: 2545-2559
• 43 ADVANCE Collaborative Group Patel A, MacMahon S. et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560-2572
• 44 Völzke H, Alte D, Schmidt CO. et al. Cohort Profile: The Study of Health in Pomerania. Int J Epidemiol 2011; 40: 294-307
• 45 Szendroedi J, Saxena A, Weber KS. et al. Cohort profile: The German Diabetes Study (GDS). Cardiovasc Diabetol 2016; 15: 59
• 46 Nathan DM. Group for the DR. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study at 30 Years: Overview. Diabetes Care 2014; 37: 9-16
• 47 Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358: 2545–2559
• 48 Bowton E, Field JR, Wang S. et al. Biobanks and Electronic Medical Records: Enabling Cost-Effective Research. Sci Transl Med 2014; 6: 234cm3-234cm3
• 49 Sudlow C, Gallacher J, Allen N. et al. UK Biobank: An open access resource for identifying the causes of a wide range of complex diseases of middle and old age. PLOS Med. 2015; 12: e1001779
• 50 Yin P, Peter A, Franken H. et al. Preanalytical aspects and sample quality assessment in metabolomics studies of human blood. Clin Chem 2013; 59: 833-845
• 51 Herzberg-Schäfer S, Heni M, Stefan N. et al. Impairment of GLP1-induced insulin secretion: Role of genetic background, insulin resistance and hyperglycaemia. Diabetes Obes Metab 2012; 14: 85-90
• 52 Ahlqvist E, Storm P, Käräjämäki A. et al. Novel subgroups of adult-onset diabetes and their association with outcomes: A data-driven cluster analysis of six variables. Lancet Diabetes Endocrinol 2018; 6: 361-369