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

Study Overview
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Brief Summary
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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
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In detail, the following questions will be answered: Are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis? Which factors modify the progression of the disease (Nutrition, subclinical inflammation, energy metabolism and physical activity)? 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.

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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes Cohort<br>Prospectively followed cohort of newly diagnosed patients with diabetes mellitus, aged 18-69 years at inclusion into the study | |
| Control Cohort<br>Prospectively followed cohort of glucose tolerant humans, aged 18-69 years at inclusion into the study | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, prospective observational study, diabetic complications