Cohort profile: the German Diabetes Study (GDS)

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Abstract

Background

The German Diabetes Study (GDS) is a prospective longitudinal cohort study describing the impact of subphenotypes on the course of the disease. GDS aims at identifying prognostic factors and mechanisms underlying the development of related comorbidities.

Study design and methods

The study comprises intensive phenotyping within 12 months after clinical diagnosis, at 5-year intervals for 20 years and annual telephone interviews in between. Dynamic tests, including glucagon, mixed meal, intravenous glucose tolerance and hyperinsulinemic clamp tests, serve to assess beta-cell function and tissue-specific insulin sensitivity. Magnetic resonance imaging and multinuclei spectroscopy allow quantifying whole-body fat distribution, tissue-specific lipid deposition and energy metabolism. Comprehensive analyses of microvascular (nerve, eye, kidney) and macrovascular (endothelial, cardiorespiratory) morphology and function enable identification and monitoring of comorbidities. The GDS biobank stores specimens from blood, stool, skeletal muscle, subcutaneous adipose tissue and skin for future analyses including multiomics, expression profiles and histology. Repeated questionnaires on socioeconomic conditions, patient-reported outcomes as quality of life, health-related behavior as physical activity and nutritional habits are a specific asset of GDS. This study will recruit 3000 patients and a group of humans without familiy history of diabetes. 237 type 1 and 456 type 2 diabetes patients have been already included.

Electronic supplementary material

The online version of this article (doi:10.1186/s12933-016-0374-9) contains supplementary material, which is available to authorized users.

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Most cited references 83

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Glucose clamp technique: a method for quantifying insulin secretion and resistance.

Christian R. Andres, Stephanie J. Tobin, R. DeFronzo (1979)

Methods for the quantification of beta-cell sensitivity to glucose (hyperglycemic clamp technique) and of tissue sensitivity to insulin (euglycemic insulin clamp technique) are described. Hyperglycemic clamp technique. The plasma glucose concentration is acutely raised to 125 mg/dl above basal levels by a priming infusion of glucose. The desired hyperglycemic plateau is subsequently maintained by adjustment of a variable glucose infusion, based on the negative feedback principle. Because the plasma glucose concentration is held constant, the glucose infusion rate is an index of glucose metabolism. Under these conditions of constant hyperglycemia, the plasma insulin response is biphasic with an early burst of insulin release during the first 6 min followed by a gradually progressive increase in plasma insulin concentration. Euglycemic insulin clamp technique. The plasma insulin concentration is acutely raised and maintained at approximately 100 muU/ml by a prime-continuous infusion of insulin. The plasma glucose concentration is held constant at basal levels by a variable glucose infusion using the negative feedback principle. Under these steady-state conditions of euglycemia, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue sensitivity to exogenous insulin.

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Depression and poor glycemic control: a meta-analytic review of the literature.

P Lustman, Paul Carney, Melvin E. Clouse … (2000)

Depression is common among patients with diabetes, but its relationship to glycemic control has not been systematically reviewed. Our objective was to determine whether depression is associated with poor glycemic control. Medline and PsycINFO databases and published reference lists were used to identify studies that measured the association of depression with glycemic control. Meta-analytic procedures were used to convert the findings to a common metric, calculate effect sizes (ESs), and statistically analyze the collective data. A total of 24 studies satisfied the inclusion and exclusion criteria for the meta-analysis. Depression was significantly associated with hyperglycemia (Z = 5.4, P < 0.0001). The standardized ES was in the small-to-moderate range (0.17) and was consistent, as the 95% CI was narrow (0.13-0.21). The ES was similar in studies of either type 1 or type 2 diabetes (ES 0.19 vs. 0.16) and larger when standardized interviews and diagnostic criteria rather than self-report questionnaires were used to assess depression (ES 0.28 vs. 0.15). Depression is associated with hyperglycemia in patients with type 1 or type 2 diabetes. Additional studies are needed to establish the directional nature of this relationship and to determine the effects of depression treatment on glycemic control and the long-term course of diabetes.

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Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus.

Kevan C. Herold, William Hagopian, Julie A Auger … (2002)

Type 1 diabetes mellitus is a chronic autoimmune disease caused by the pathogenic action of T lymphocytes on insulin-producing beta cells. Previous clinical studies have shown that continuous immune suppression temporarily slows the loss of insulin production. Preclinical studies suggested that a monoclonal antibody against CD3 could reverse hyperglycemia at presentation and induce tolerance to recurrent disease. We studied the effects of a nonactivating humanized monoclonal antibody against CD3--hOKT3gamma1(Ala-Ala)--on the loss of insulin production in patients with type 1 diabetes mellitus. Within 6 weeks after diagnosis, 24 patients were randomly assigned to receive either a single 14-day course of treatment with the monoclonal antibody or no antibody and were studied during the first year of disease. Treatment with the monoclonal antibody maintained or improved insulin production after one year in 9 of the 12 patients in the treatment group, whereas only 2 of the 12 controls had a sustained response (P=0.01). The treatment effect on insulin responses lasted for at least 12 months after diagnosis. Glycosylated hemoglobin levels and insulin doses were also reduced in the monoclonal-antibody group. No severe side effects occurred, and the most common side effects were fever, rash, and anemia. Clinical responses were associated with a change in the ratio of CD4+ T cells to CD8+ T cells 30 and 90 days after treatment. Treatment with hOKT3gamma1(Ala-Ala) mitigates the deterioration in insulin production and improves metabolic control during the first year of type 1 diabetes mellitus in the majority of patients. The mechanism of action of the anti-CD3 monoclonal antibody may involve direct effects on pathogenic T cells, the induction of populations of regulatory cells, or both.

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Author and article information

Contributors

Julia Szendroedi: Julia.Szendroedi@ddz.uni-duesseldorf.de

Aaruni Saxena: Aaruni.Saxena@ddz.uni-duesseldorf.de

Katharina S. Weber: Katharina.Weber@ddz.uni-duesseldorf.de

Klaus Strassburger: Klaus.Strassburger@ddz.uni-duesseldorf.de

Christian Herder: Christian.Herder@ddz.uni-duesseldorf.de

Volker Burkart: Volker.Burkart@ddz.uni-duesseldorf.de

Bettina Nowotny: Bettina.Nowotny@ddz.uni-duesseldorf.de

Andrea Icks: Andrea.Icks@ddz.uni-duesseldorf.de

Oliver Kuss: Oliver.Kuss@ddz.uni-duesseldorf.de

Dan Ziegler: Dan.Ziegler@ddz.uni-duesseldorf.de

Hadi Al-Hasani: Hadi.Al-Hasani@ddz.uni-duesseldorf.de

Karsten Müssig: Karsten.Muessig@ddz.uni-duesseldorf.de

Michael Roden: + 49 211 3382 201 , Michael.Roden@ddz.uni-duesseldorf.de

Journal

Journal ID (nlm-ta): Cardiovasc Diabetol

Journal ID (iso-abbrev): Cardiovasc Diabetol

Title: Cardiovascular Diabetology

Publisher: BioMed Central (London )

ISSN (Electronic): 1475-2840

Publication date (Electronic): 7 April 2016

Publication date PMC-release: 7 April 2016

Publication date Collection: 2016

Volume: 15

Electronic Location Identifier: 59

Affiliations

[ ]Institute for Clinical Diabetology, Leibniz Institute for Diabetes Research, German Diabetes Center at Heinrich Heine University, Düsseldorf, Germany

[ ]German Center for Diabetes Research (DZD), München-Neuherberg, Germany

[ ]Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany

[ ]Institute for Biometrics and Epidemiology, Leibniz Institute for Diabetes Research, German Diabetes Center at Heinrich Heine University, Düsseldorf, Germany

[ ]Public Health Unit, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany

[ ]Institute for Clinical Biochemistry and Pathobiochemistry German Diabetes Center, Leibniz Institute for Diabetes Research, Düsseldorf, Germany

Article

Publisher ID: 374

DOI: 10.1186/s12933-016-0374-9

PMC ID: 4823856

PubMed ID: 27053136

SO-VID: 42a06e6c-f832-4c26-b206-be04a19d0514

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 10 December 2015

Date accepted : 24 March 2016

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100002347, Bundesministerium für Bildung und Forschung;

Award ID: FKZ 82DZD00201

Funded by: Deutsches Zentrum für Diabetesforschung (DZD)

Award ID: FKZ 82DZD00201

Funded by: FundRef http://dx.doi.org/10.13039/501100003107, Bundesministerium für Gesundheit;

Custom metadata

ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: insulin resistance,magnetic resonance spectroscopy,beta cell function,metabolic phenotyping,diabetes comorbidities

Data availability:

ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: insulin resistance, magnetic resonance spectroscopy, beta cell function, metabolic phenotyping, diabetes comorbidities

Cohort profile: the German Diabetes Study (GDS)

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Abstract

Background

Study design and methods

Electronic supplementary material

Related collections

Journal of the ASEAN Federation of Endocrine Societies

Most cited references 83

Glucose clamp technique: a method for quantifying insulin secretion and resistance.

Depression and poor glycemic control: a meta-analytic review of the literature.

Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus.

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