Dataset Information

Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2.

ABSTRACT:

Background

Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE).

Methods

DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro- and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e.g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness.

Discussion

DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies.

SUBMITTER: Dorhofer L

PROVIDER: S-EPMC3577512 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2.

Dörhöfer Lena L Lammert Alexander A Krane Vera V Gorski Mathias M Banas Bernhard B Wanner Christoph C Krämer Bernhard K BK Heid Iris M IM Böger Carsten A CA

BMC medical genetics 20130214

<h4>Background</h4>Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE).<h4>Methods</h4>DIACORE is a prospective coh ...[more]

PMID: 23409726

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Project description:Hypothesis: Positive airway pressure (PAP) is the standard treatment for sleep-disordered breathing (SDB), a prevalent condition in patients with type 2 diabetes mellitus (DM2). Recent studies showed that short-term PAP treatment may cause weight gain. However, long-term data for patients with DM2 are scarce. Therefore, the aim of the present analysis was to assess changes in weight and glycemic control in patients with DM2 and treated vs. untreated SDB. Methods: The DIAbetes COhoRtE (DIACORE) study is a prospective population-based cohort study in patients with DM2. At baseline, patients of the DIACORE-SDB sub-study were tested for SDB [defined as apnea-hypopnea-index (AHI) ≥ 15/h] using a two-channel ambulatory SDB-monitoring device. In this observational study, PAP treatment was initiated in a subgroup of patients with SDB (SDB PAP) within clinical routine between the baseline and first follow-up visit [median observation period of 2.3 (2.2; 2.4) years], whereas the other patients with SDB did not receive PAP (SDB untreated). At baseline and first follow-up visit, weight and HbA1c were assessed. Results: Of the 346 patients with SDB [mean age 68 years, 71% male, body-mass index (BMI) 31.9 kg/m2], 17% were in the SDB PAP and 83% in the SDB untreated group. Weight change within the observation period was similar in both groups (-0.2 and -0.9 kg; p = 0.322). The percentage of patients with severe weight gain (≥ 5 kg) within the observation period was significantly higher in the SDB PAP group compared to the SDB untreated group (15.0 vs. 5.6%; p = 0.011). Multivariable regression analysis, accounting for baseline HbA1c, insulin substitution, BMI, waist-to-hip ratio (WHR), physical activity, and AHI, showed that PAP treatment was significantly associated with a weight gain ≥ 5 kg [odds ratio (OR) = 3.497; 95% CI (1.343; 9.106); p = 0.010] and an increase in HbA1c [B = 2.410; 95% CI (0.118; 4.702); p = 0.039]. Conclusion: Median weight change was similar in patients with SDB with and without PAP treatment. However, patients with DM2 and PAP treatment have an increased risk of severe long-term weight gain and an increase in HbA1c. Clinical Trial registration: DRKS00010498.

Project description:BackgroundWe compared all-cause mortality, major macrovascular events (MACE) and diabetes-related hospitalizations in T2DM-incident patients newly treated with metformin (MET) versus sulphonylureas (SU) monotherapy and in T2DM-prevalent patients newly treated with MET+SU versus MET+DPP4-inhibitor combination therapy.MethodsWe analysed anonymized data obtained from a German health fund. Patients were included when they had started MET versus SU therapy or MET+SU versus MET+DPP4 therapy between 01/07/2010 and 31/12/2011. Observation started with the first MET/SU prescription or the first prescription of the second agent of a MET+SU/MET+DPP4 combination therapy. Follow-up time lasted until the end of data availability (a minimum of 12 months), death or therapy discontinuation.ResultsIn total, 434,291 T2DM-prevalent and 35,661 T2DM-incident patients were identified. Of the identified T2DM-incident patients, 904/7,874 started SU/MET monotherapy, respectively, with a mean age of 70.1/61.4 years (54.6/50.3 % female; Charlson Comorbidity Index (CCI) 1.4/2.2; 933/7,350 observed SU/MET patient years). 4,157/1,793 SU+MET/DPP4+MET therapy starters had a mean age of 68.1/62.2 years (53.4/50.8 % female; CCI 2.8/2.6; 4,556/1,752 observed SU+MET/ DPP4+MET patient years). In a propensity score matched (PSM) comparison, the HRs (95 % CIs) associated with SU monotherapy compared to MET monotherapy exposure were 1.4 (0.9-2.3) for mortality, 1.4 (0.9-2.2) for MACE, 4.1 (1.5-10.9) for T2DM hospitalizations and 1.6 (1.2-2.3) for composite event risk. In a multivariable Cox regression model, SU monotherapy was associated with higher mortality (aHR 2.0; 1.5-2.6), higher MACE (aHR 1.3; 1.0-1.7) and higher T2DM hospitalizations (aHR 2.8; 1.8-4.4), which corresponded with a higher composite event risk (aHR 1.8; 1.5-2.1). No significant differences in event rates were observed in the PSM comparison between DPP4+MET/SU+MET combination therapy starters and in the multivariable Cox regression analysis.ConclusionsOur results show that SU monotherapy may be associated with increased mortality, MACE and T2DM hospitalizations, compared to MET monotherapy. When considering SU therapy, the associated cardiovascular risk should also be taken into account.

Dataset Information

Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2.

Background

Methods

Discussion

Publications

Study design of DIACORE (DIAbetes COhoRtE) - a cohort study of patients with diabetes mellitus type 2.

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