Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, prospective observational study, diabetic complications

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.

Katharina S. Weber, Sabrina Schlesinger, Alexander Lang, Janina Goletzke, Cara Övermöhle et al. (28 authors)

Scientific Reports2026-07-06

10.1038/s41598-026-57026-y

Systemic Inflammation and Peripheral T Cell Responses Associate With Hepatic Energy Metabolism in Recent-Onset Type 1 Diabetes.

Ratter-Rieck JM, Zepina A, Huttasch M, Kupriyanova Y, Petrera A, Trenkamp S, Wagner R, Schrauwen-Hinderling V, Herder C, Roden M, GDS group.

2026-06-01

10.1111/liv.70693

Comparison of Vyntus CPX and Vmax Encore 29N for indirect calorimetry: a randomised crossover study in participants of the German Diabetes Study with type 2 diabetes.

Trinks N, Pützer J, Sutkowski A, Burkart V, Roden M, Kuss O.

2025-12-10

10.1136/bmjopen-2025-104761

<sup>31</sup>P-MRS saturation transfer for assessing human hepatic ATP synthesis at clinical field strength.

Jonuscheit M, Korzekwa B, Schär M, Mevenkamp J, Wierichs S, Bobrov P, Sarabhai T, Kahl S, Roden M, Schrauwen-Hinderling VB.

2025-05-13

10.1186/s41747-025-00588-9

Macular perfusion alterations in people with recent-onset diabetes and novel diabetes subtypes.

Kaya S, Khamees A, Geerling G, Strzalkowski P, Gontscharuk V, Szendroedi J, Müssig K, Ziegler D, Roden M, Guthoff R, GDS Cohort.

2025-03-311 citations

10.1007/s00125-025-06407-5

Associations of carbohydrate quality and cardiovascular risk factors vary among diabetes subtypes.

Weber KS, Schlesinger S, Goletzke J, Straßburger K, Zaharia OP, Trenkamp S, Wagner R, Lieb W, Buyken AE, Roden M, Herder C, GDS group.

2025-02-062 citations

10.1186/s12933-025-02580-4

Three-protein signature is associated with baseline and persistently elevated or recurrent depressive symptoms in individuals with recent-onset diabetes

Maria C. Spagnuolo, Pascal Gottmann, Jana Sommer, Sandra Olivia Borgmann, Klaus Straßburger et al. (13 authors)

BMJ Open Diabetes Research & Care2025-01-01

10.1136/bmjdrc-2024-004396

Alterations of hepatic lipid content following COVID-19 in persons with type 2 diabetes

Yuliya Kupriyanova, Iryna Yurchenko, Pavel Bobrov, Frederik Bartels, Stefan Wierichs et al. (15 authors)

BMJ Open Diabetes Research & Care2025-01-01

10.1136/bmjdrc-2024-004727

Association of dietary patterns with diabetes-related comorbidities varies among diabetes endotypes.

Weber KS, Schlesinger S, Lang A, Straßburger K, Maalmi H, Zhu A, Zaharia OP, Strom A, Bönhof GJ, Goletzke J, Trenkamp S, Wagner R, Buyken AE, Lieb W, Roden M, Herder C, GDS group.

2024-01-058 citations

10.1016/j.numecd.2023.12.026

Association of a lifestyle score with cardiometabolic markers among individuals with diabetes: a cross-sectional study

Christina Baechle, Alexander Lang, Klaus Straßburger, Oliver Kuß, Volker Burkart et al. (12 authors)

BMJ Open Diabetes Research & Care2023-07-019 citations

10.1136/bmjdrc-2023-003469

Hepatic energy metabolism in a family with a glucokinase gene mutation and dysglycemia.

Bódis K, Knebel B, Nowotny B, Bobrov P, Kupriyanova Y, Zaharia OP, Karusheva Y, Schön M, Wolkersdorfer M, Burkart V, Al-Hasani H, Markgraf D, Müssig K, Roden M, Szendroedi J, GDS study group.

2022-02-14

10.1016/j.diabres.2022.109779

NDUFB6 Polymorphism Is Associated With Physical Activity-Mediated Metabolic Changes in Type 2 Diabetes

Dominik Pesta, Tomáš Jeleník, Oana‐Patricia Zaharia, Pavel Bobrov, Sven W. Görgens et al. (18 authors)

Frontiers in Endocrinology2021-09-249 citations

10.3389/fendo.2021.693683

Impact of mixed meal tolerance test composition on measures of beta-cell function in type 2 diabetes

Theresa Kössler, Pavel Bobrov, Klaus Straßburger, Oliver Kuß, Oana‐Patricia Zaharia et al. (30 authors)

Nutrition & Metabolism2021-05-0418 citations

10.1186/s12986-021-00556-1

Early changes in hepatic energy metabolism and lipid content in recent-onset type 1 and 2 diabetes mellitus

Yuliya Kupriyanova, Oana‐Patricia Zaharia, Pavel Bobrov, Yanislava Karusheva, Volker Burkart et al. (25 authors)

Journal of Hepatology2020-11-2864 citations

10.1016/j.jhep.2020.11.030

Risk of diabetes-associated diseases in subgroups of patients with recent-onset diabetes: a 5-year follow-up study.

Zaharia OP, Strassburger K, Strom A, Bönhof GJ, Karusheva Y, Antoniou S, Bódis K, Markgraf DF, Burkart V, Müssig 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, Häring HU, Ziegler D, Kuss O, Szendroedi J, Roden M, German Diabetes Study Group.

2019-07-22341 citations

10.1016/s2213-8587(19)30187-1

A variant of the glucose transporter gene SLC2A2 modifies the glycaemic response to metformin therapy in recently diagnosed type 2 diabetes.

Rathmann W, Strassburger K, Bongaerts B, Kuss O, Müssig K, Burkart V, Szendroedi J, Kotzka J, Knebel B, Al-Hasani H, Roden M, GDS Group.

2018-11-0923 citations

10.1007/s00125-018-4759-z

What information needs do people with recently diagnosed diabetes mellitus have and what are the associated factors? A cross-sectional study in Germany

Sandra Grobosch, Silke Kuske, Ute Linnenkamp, Nicole Ernstmann, Astrid Stephan et al. (13 authors)

BMJ Open2018-10-0122 citations

10.1136/bmjopen-2017-017895

German Diabetes Study – Baseline data of retinal layer thickness measured by<scp>SD</scp>‐<scp>OCT</scp>in early diabetes mellitus

K. Schröder, Julia Szendroedi, Anna Benthin, Veronika Gontscharuk, Philipp Ackermann et al. (15 authors)

Acta Ophthalmologica2018-09-2112 citations

10.1111/aos.13851

Cognitive Function Is Impaired in Patients with Recently Diagnosed Type 2 Diabetes, but Not Type 1 Diabetes

Theresa van Gemert, Wolfgang Wölwer, Katharina S. Weber, Annika Hoyer, Klaus Straßburger et al. (14 authors)

Journal of Diabetes Research2018-08-0919 citations

10.1155/2018/1470476

Circulating adiponectin concentration is inversely associated with glucose tolerance and insulin secretion in people with newly diagnosed diabetes

Katharina S. Weber, Klaus Straßburger, Giovanni Pacini, Bettina Nowotny, Karsten Müssig et al. (9 authors)

Diabetic Medicine2016-10-228 citations

10.1111/dme.13278

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.

Weber KS, Knebel B, Strassburger K, Kotzka J, Stehle P, Szendroedi J, Müssig K, Buyken AE, Roden M, GDS Group.

2016-09-2718 citations

10.1186/s12933-016-0455-9

Metabolic flexibility and oxidative capacity independently associate with insulin sensitivity in individuals with newly diagnosed type 2 diabetes.

Apostolopoulou M, Strassburger K, Herder C, Knebel B, Kotzka J, Szendroedi J, Roden M, GDS group.

2016-07-0423 citations

10.1007/s00125-016-4038-9

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change of insulin sensitivity (M-Value)	2 and 5 years	measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary

Measure	Time frame	Description
Change of insulin secretion	2 and 5 years	measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test
Incidence of any diabetic complication	2-10 years	The prevalence of diabetic complications

Countries

Germany

Contacts

Primary ContactRobert Wagner, Prof., MD

robert.wagner@ddz.de+49-211-3382

Backup ContactPetra Heidkamp

studienzentrum@ddz.de+49-211-3382

Outcome results