Clinical trial NCT01055093: Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Official title: Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
prospective observational study
diabetic complications
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the general populations by screening

Brief summary: The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.

Detailed description: In detail, the following questions will be answered:

1. Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis?
2. Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)?
3. Can we identify subgroups at baseline with different progression of the disease? Patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus according to ADA criteria
* Age 18-69
* Diabetes duration since diagnosis \< 12 months
* Control cohort: proven normal glucose tolerance according to ADA criteria

Exclusion Criteria:

* Diabetes mellitus category 3 B-H (ADA criteria)
* Pregnancy
* Severe renal, liver or heart disease
* malignant cancer
* severe psychiatric illness or addiction
* participation in an intervention trial

Primary outcomes:
measure: Change of insulin sensitivity (M-Value)
timeFrame: 2 and 5 years
Secondary outcomes:
measure: Change of insulin secretion
timeFrame: 2 and 5 years
measure: Incidence of any diabetic complication
timeFrame: 2-10 years
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center
state: North-Rhine Westphalia
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szendroedi J, Saxena A, Weber KS, Strassburger K, Herder C, Burkart V, Nowotny B, Icks A, Kuss O, Ziegler D, Al-Hasani H, Mussig K, Roden M; GDS Group. Cohort profile: the German Diabetes Study (GDS). Cardiovasc Diabetol. 2016 Apr 7;15:59. doi: 10.1186/s12933-016-0374-9.
citation: Kossler T, Bobrov P, Strassburger K, Kuss O, Zaharia OP, Karusheva Y, Moser C, Bodis K, Burkart V, Roden M, Szendroedi J; GDS Group. Impact of mixed meal tolerance test composition on measures of beta-cell function in type 2 diabetes. Nutr Metab (Lond). 2021 May 4;18(1):47. doi: 10.1186/s12986-021-00556-1.
citation: Kupriyanova Y, Zaharia OP, Bobrov P, Karusheva Y, Burkart V, Szendroedi J, Hwang JH, Roden M; GDS group. Early changes in hepatic energy metabolism and lipid content in recent-onset type 1 and 2 diabetes mellitus. J Hepatol. 2021 May;74(5):1028-1037. doi: 10.1016/j.jhep.2020.11.030. Epub 2020 Nov 28.
citation: Zaharia OP, Strassburger K, Knebel B, Kupriyanova Y, Karusheva Y, Wolkersdorfer M, Bodis K, Markgraf DF, Burkart V, Hwang JH, Kotzka J, Al-Hasani H, Szendroedi J, Roden M; GDS Group. Role of Patatin-Like Phospholipase Domain-Containing 3 Gene for Hepatic Lipid Content and Insulin Resistance in Diabetes. Diabetes Care. 2020 Sep;43(9):2161-2168. doi: 10.2337/dc20-0329. Epub 2020 Jun 19.
citation: Maalmi H, Herder C, Strassburger K, Urner S, Jandeleit-Dahm K, Zaharia OP, Karusheva Y, Bongaerts BWC, Rathmann W, Burkart V, Szendroedi J, Roden M. Biomarkers of Inflammation and Glomerular Filtration Rate in Individuals with Recent-Onset Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa622. doi: 10.1210/clinem/dgaa622.
citation: Kanti G, Anadol-Schmitz E, Bobrov P, Strassburger K, Kahl S, Zaharia OP, Sarabhai T, Karusheva Y, Burkart V, Markgraf DF, Trenkamp S, Ziegler D, Szendroedi J, Roden M; GDS Group. Vitamin B12 and Folate Concentrations in Recent-onset Type 2 Diabetes and the Effect of Metformin Treatment. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa150. doi: 10.1210/clinem/dgaa150.
citation: Bodis K, Jelenik T, Lundbom J, Markgraf DF, Strom A, Zaharia OP, Karusheva Y, Burkart V, Mussig K, Kupriyanova Y, Ouni M, Wolkersdorfer M, Hwang JH, Ziegler D, Schurmann A, Roden M, Szendroedi J; GDS Study Group. Expansion and Impaired Mitochondrial Efficiency of Deep Subcutaneous Adipose Tissue in Recent-Onset Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1331-43. doi: 10.1210/clinem/dgz267.
citation: Puttgen S, Bonhof GJ, Strom A, Mussig K, Szendroedi J, Roden M, Ziegler D. Augmented Corneal Nerve Fiber Branching in Painful Compared With Painless Diabetic Neuropathy. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6220-6228. doi: 10.1210/jc.2019-01072.
citation: Zaharia OP, Strassburger K, Strom A, Bonhof GJ, Karusheva Y, Antoniou S, Bodis K, Markgraf DF, Burkart V, Mussig K, Hwang JH, Asplund O, Groop L, Ahlqvist E, Seissler J, Nawroth P, Kopf S, Schmid SM, Stumvoll M, Pfeiffer AFH, Kabisch S, Tselmin S, Haring HU, Ziegler D, Kuss O, Szendroedi J, Roden M; German Diabetes Study Group. Risk of diabetes-associated diseases in subgroups of patients with recent-onset diabetes: a 5-year follow-up study. Lancet Diabetes Endocrinol. 2019 Sep;7(9):684-694. doi: 10.1016/S2213-8587(19)30187-1. Epub 2019 Jul 22.
citation: Simon MC, Moller-Horigome A, Strassburger K, Nowotny B, Knebel B, Mussig K, Herder C, Szendroedi J, Roden MW; German Diabetes Study Group. Correlates of Insulin-Stimulated Glucose Disposal in Recent-Onset Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2295-2304. doi: 10.1210/jc.2018-02057.
citation: Rathmann W, Strassburger K, Bongaerts B, Kuss O, Mussig K, Burkart V, Szendroedi J, Kotzka J, Knebel B, Al-Hasani H, Roden M; GDS Group. A variant of the glucose transporter gene SLC2A2 modifies the glycaemic response to metformin therapy in recently diagnosed type 2 diabetes. Diabetologia. 2019 Feb;62(2):286-291. doi: 10.1007/s00125-018-4759-z. Epub 2018 Nov 9.
citation: Grobosch S, Kuske S, Linnenkamp U, Ernstmann N, Stephan A, Genz J, Begun A, Haastert B, Szendroedi J, Mussig K, Burkart V, Roden M, Icks A; GDS Group. What information needs do people with recently diagnosed diabetes mellitus have and what are the associated factors? A cross-sectional study in Germany. BMJ Open. 2018 Oct 31;8(10):e017895. doi: 10.1136/bmjopen-2017-017895.
citation: Schroder K, Szendroedi J, Benthin A, Gontscharuk V, Ackermann P, Volker M, Steingrube N, Nowotny B, Ziegler D, Mussig K, Geerling G, Kuss O, Roden M, Guthoff R; GDS Cohort. German Diabetes Study - Baseline data of retinal layer thickness measured by SD-OCT in early diabetes mellitus. Acta Ophthalmol. 2019 Mar;97(2):e303-e307. doi: 10.1111/aos.13851. Epub 2018 Sep 21.
citation: van Gemert T, Wolwer W, Weber KS, Hoyer A, Strassburger K, Bohnau NT, Bruggen MA, Ovelgonne K, Gossmann EM, Burkart V, Szendroedi J, Roden M, Mussig K; GDS Group. Cognitive Function Is Impaired in Patients with Recently Diagnosed Type 2 Diabetes, but Not Type 1 Diabetes. J Diabetes Res. 2018 Aug 9;2018:1470476. doi: 10.1155/2018/1470476. eCollection 2018.
citation: Ziegler D, Strom A, Kupriyanova Y, Bierwagen A, Bonhof GJ, Bodis K, Mussig K, Szendroedi J, Bobrov P, Markgraf DF, Hwang JH, Roden M; GDS Group. Association of Lower Cardiovagal Tone and Baroreflex Sensitivity With Higher Liver Fat Content Early in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1130-1138. doi: 10.1210/jc.2017-02294.
citation: Zaharia OP, Bobrov P, Strassburger K, Bodis K, Karusheva Y, Scholz M, Markgraf DF, Burkart V, Schloot NC, Mussig K, Szendroedi J, Roden M; GDS Group. Metabolic Characteristics of Recently Diagnosed Adult-Onset Autoimmune Diabetes Mellitus. J Clin Endocrinol Metab. 2018 Feb 1;103(2):429-437. doi: 10.1210/jc.2017-01706.
citation: Rohling M, Strom A, Bonhof G, Puttgen S, Bodis K, Mussig K, Szendrodi J, Markgraf D, Lehr S, Roden M, Ziegler D; German Diabetes Study Group. Differential Patterns of Impaired Cardiorespiratory Fitness and Cardiac Autonomic Dysfunction in Recently Diagnosed Type 1 and Type 2 Diabetes. Diabetes Care. 2017 Feb;40(2):246-252. doi: 10.2337/dc16-1898. Epub 2016 Nov 29.
citation: Weber KS, Strassburger K, Pacini G, Nowotny B, Mussig K, Szendroedi J, Herder C, Roden M; German Diabetes Study group. Circulating adiponectin concentration is inversely associated with glucose tolerance and insulin secretion in people with newly diagnosed diabetes. Diabet Med. 2017 Feb;34(2):239-244. doi: 10.1111/dme.13278. Epub 2016 Nov 17.
citation: Weber KS, Knebel B, Strassburger K, Kotzka J, Stehle P, Szendroedi J, Mussig K, Buyken AE, Roden M; GDS Group. Associations between explorative dietary patterns and serum lipid levels and their interactions with ApoA5 and ApoE haplotype in patients with recently diagnosed type 2 diabetes. Cardiovasc Diabetol. 2016 Sep 27;15(1):138. doi: 10.1186/s12933-016-0455-9.
citation: Apostolopoulou M, Strassburger K, Herder C, Knebel B, Kotzka J, Szendroedi J, Roden M; GDS group. Metabolic flexibility and oxidative capacity independently associate with insulin sensitivity in individuals with newly diagnosed type 2 diabetes. Diabetologia. 2016 Oct;59(10):2203-7. doi: 10.1007/s00125-016-4038-9. Epub 2016 Jul 4.
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citation: Knebel B, Strassburger K, Szendroedi J, Kotzka J, Scheer M, Nowotny B, Mussig K, Lehr S, Pacini G, Finner H, Kluppelholz B, Giani G, Al-Hasani H, Roden M; German Diabetes Study Group. Specific Metabolic Profiles and Their Relationship to Insulin Resistance in Recent-Onset Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2016 May;101(5):2130-40. doi: 10.1210/jc.2015-4133. Epub 2016 Feb 1.
citation: Weber KS, Nowotny B, Strassburger K, Pacini G, Mussig K, Szendroedi J, Herder C, Roden M; GDS Group. The Role of Markers of Low-Grade Inflammation for the Early Time Course of Glycemic Control, Glucose Disappearance Rate, and beta-Cell Function in Recently Diagnosed Type 1 and Type 2 Diabetes. Diabetes Care. 2015 Sep;38(9):1758-67. doi: 10.2337/dc15-0169. Epub 2015 Jul 7.
citation: Menart-Houtermans B, Rutter R, Nowotny B, Rosenbauer J, Koliaki C, Kahl S, Simon MC, Szendroedi J, Schloot NC, Roden M; German Diabetes Study Group. Leukocyte profiles differ between type 1 and type 2 diabetes and are associated with metabolic phenotypes: results from the German Diabetes Study (GDS). Diabetes Care. 2014 Aug;37(8):2326-33. doi: 10.2337/dc14-0316.
citation: Goletzke J, Weber KS, Kossler T, Zaharia OP, Bodis K, Mussig K, Szendroedi J, Burkart V, Stutz B, Nothlings U, Buyken AE, Roden M; GDS Group. Relative validity of a glycemic index extended food-frequency questionnaire. Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2310-2320. doi: 10.1016/j.numecd.2022.07.007. Epub 2022 Jul 16.
citation: Zaharia OP, Schon M, Loffler L, Strassburger K, Moser C, Yurchenko I, Bodis K, Antoniou S, Karusheva Y, Szendroedi J, Burkart V, Roden M. Metabolic Factors Predict Changes in Endothelial Function During the Early Course of Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):e4167-e4176. doi: 10.1210/clinem/dgac480.
citation: Bodis K, Knebel B, Nowotny B, Bobrov P, Kupriyanova Y, Zaharia OP, Karusheva Y, Schon M, Wolkersdorfer M, Burkart V, Al-Hasani H, Markgraf D, Mussig K, Roden M, Szendroedi J; GDS study group. Hepatic energy metabolism in a family with a glucokinase gene mutation and dysglycemia. Diabetes Res Clin Pract. 2022 Mar;185:109779. doi: 10.1016/j.diabres.2022.109779. Epub 2022 Feb 14.
citation: Saatmann N, Zaharia OP, Strassburger K, Pesta DH, Burkart V, Szendroedi J, Gerdes N, Kelm M, Roden M. Physical Fitness and Cardiovascular Risk Factors in Novel Diabetes Subgroups. J Clin Endocrinol Metab. 2022 Mar 24;107(4):1127-1139. doi: 10.1210/clinem/dgab810.
citation: Pesta D, Jelenik T, Zaharia OP, Bobrov P, Gorgens S, Bodis K, Karusheva Y, Krako Jakovljevic N, Lalic NM, Markgraf DF, Burkart V, Mussig K, Knebel B, Kotzka J, Eckel J, Strassburger K, Szendroedi J, Roden M. NDUFB6 Polymorphism Is Associated With Physical Activity-Mediated Metabolic Changes in Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Sep 24;12:693683. doi: 10.3389/fendo.2021.693683. eCollection 2021.
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