Heidelberg Study on Diabetes and Complications (HEIST-DiC)
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ClinicalTrials.gov Identifier: NCT03022721 |
Recruitment Status :
Recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
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Condition or disease | Intervention/treatment |
---|---|
Diabetes Complications | Other: No interventions are planned for this study. |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Heidelberg Study on Diabetes and Complications |
Study Start Date : | September 2016 |
Estimated Primary Completion Date : | September 2027 |
Estimated Study Completion Date : | September 2028 |
Group/Cohort | Intervention/treatment |
---|---|
Patients with diabetes
Patients with both type 1 and type 2 Diabetes will be enrolled, Independent of Diabetes Duration, therapy etc. No interventions are planned. |
Other: No interventions are planned for this study.
No interventions are planned for this study, it is purely observational. |
Pre-Diabetics
Patients who have either imparied fasting Glucose or impaired Glucose tolerance in the oral Glucose tolerance test. No interventions are planned. |
Other: No interventions are planned for this study.
No interventions are planned for this study, it is purely observational. |
Healthy controls
Study participants without Diabetes or Pre-diabetes in the oral Glucose tolerance test. no interventions are planned. |
Other: No interventions are planned for this study.
No interventions are planned for this study, it is purely observational. |
- Development of diabetic complications [ Time Frame: 10 years ]Diabetic complications include diabetic nephropathy, diabetic retinopathy, diabetic polyneuropathy, autonomous neuropathy, or macrovascular complications such as stroke, peripheral artery disease, or myocardial infarction.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria Age between 18 and 75 years Persons with manifest diabetes mellitus type 1 or type 2 and diagnosis according to DDG guidelines 2011, that is HbA1c of 6,5 percent or higher after exclusion of false values, more than 200 mg per dl two hours after glucose in the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice Healthy persons without diabetes or impairment of glucose metabolism in the oGTT according to DDG guidelines 2011 fasting plasma glucose less than 100 mg per dl and 2 hour plasma glucose less than 140 mg per dl Pre diabetics with impaired fasting glucose between 100 mg per dl and 125 mg per dl, or impaired glucose tolerance with 2 hour glucose values between 140 and 199 mg per dl in the oGTT, all values from venous plasma
Exclusion Criteria General exclusion criteria Secondary types of Diabetes, ADA criteria type 3 B H Current pregnancy Acute infections or fever Immune suppressant therapy Severe psychiatric diseases requiring treatment, including personality disorders, schizophrenia, depression Known alcohol or drug dependency Severe heart NYHA stadium IV, kidney, or liver insufficiency Non diabetic liver disease, for example PBC, PSC, Wilsons disease, hemochromatosis, autoimmune hepatitis severe peripheral artery disease stadium IV non diabetic glomerulopathy Cancer or other malignant diseases within the last 5 years Infectious diseases like hepatitis B, C, E, or HIV Other severe autoimmune diseases Current participation in an interventional study Anemia or disorders of bone marrow Exclusion criteria for MRI Pacemaker or ICD Metallic and magnetic implants, for example mechanic cardiac valves replacements, joint prostheses, clips after vascular surgery, middle or inner ear implants, recent tooth implants, penile implants Waist circumference more than 135 cm Claustrophobia Allergies against MRI contrast Impaired kidney function with a GFR less than 65 ml per min
Exclusion criteria for clamp study Past history of deep vein thrombosis or pulmonary embolism Routine laboratory test results less than 80 percent below lower reference value of Ferritin, iron, leucocytes, hemoglobin, hematocrite, RBC, platelets, blood alcohol Level
Exclusion criteria for bioimpedance measurement Pacemaker or ICD
Exclusion criteria for lung function testing Ignoring or non understanding of the instructions Body weight more than 160 kg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022721
Contact: Stefan Kopf, MD | +49-6221-56 ext 37790 | stefan.kopf@med.uni-heidelberg.de | |
Contact: Jan B Groener, MD | +49-6221-56 ext 37639 | jan.groener@med.uni-heidelberg.de |
Germany | |
Department of Medicine, University of Heidelberg | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Stefan Kopf, MD +49-6221- ext 37790 stefan.kopf@med.uni-heidelberg.de | |
Contact: Jan B Groener, MD +49-6221- ext 37639 jan.groener@med.uni-heidelberg.de | |
Principal Investigator: Stefan Kopf, MD | |
Sub-Investigator: Jan B Groener, MD | |
Sub-Investigator: Peter P Nawroth, Prof. |
Principal Investigator: | Stefan Kopf, MD | Head of the Clinical Study Center for Diabetes Research |
Responsible Party: | Stefan Kopf MD, Head of the Clinical Study Center for Diabetes Research, Heidelberg University |
ClinicalTrials.gov Identifier: | NCT03022721 |
Other Study ID Numbers: |
S-383/2016 |
First Posted: | January 16, 2017 Key Record Dates |
Last Update Posted: | January 16, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No sharing of individual participant data is planned. |
Diabetes Mellitus Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |