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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
Sponsor:
Information provided by (Responsible Party):
Stefan Kopf MD, Heidelberg University

Brief Summary:
The prospective observational study entitled "Heidelberg Study on Diabetes and Complications" is designed to Monitor the presence and development of diabetic complications in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic mechanisms or new risk factors for the development of diabetic complications in order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.

Condition or disease Intervention/treatment
Diabetes Complications Other: No interventions are planned for this study.

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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
Plasma, serum, PBMC, whole blood, urine. There is a possibility of DNA extraction from PBMC


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Study Population comprises patients with Diabetes, patients with pre-diabetes, and healthy controls. In total, 500 participants shall be enrolled and observed for 10 years.
Criteria

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


Information from the National Library of Medicine

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


Contacts
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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

Locations
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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.         
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Stefan Kopf, MD Head of the Clinical Study Center for Diabetes Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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.
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases