Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT03022721

Heidelberg Study on Diabetes and Complications

Led by Heidelberg University · Updated on 2017-01-16

500

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Heidelberg Study on Diabetes and Complications

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Diagnosis of type 1 or type 2 diabetes according to 2011 DDG guidelines with HbA1c ≥ 6.5%, or fasting glucose >126 mg/dl, or glucose >200 mg/dl after 2 hours in oGTT, or spontaneous glucose >200 mg/dl at least twice
  • Healthy persons without diabetes or glucose metabolism impairment with fasting plasma glucose <100 mg/dl and 2-hour plasma glucose <140 mg/dl in oGTT
  • Pre-diabetics with impaired fasting glucose between 100 and 125 mg/dl or impaired glucose tolerance with 2-hour glucose between 140 and 199 mg/dl in oGTT
Not Eligible

You will not qualify if you...

  • 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 failure NYHA stage IV, kidney or liver insufficiency
  • Non-diabetic liver diseases such as PBC, PSC, Wilson's disease, hemochromatosis, autoimmune hepatitis
  • Severe peripheral artery disease stage 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 bone marrow disorders
  • Pacemaker or ICD
  • Metallic or magnetic implants such as mechanical cardiac valves, joint prostheses, vascular clips, ear implants, recent tooth or penile implants
  • Waist circumference more than 135 cm
  • Claustrophobia
  • Allergies against MRI contrast
  • Impaired kidney function with GFR less than 65 ml/min
  • Past history of deep vein thrombosis or pulmonary embolism
  • Routine lab results less than 80% below lower reference for ferritin, iron, leukocytes, hemoglobin, hematocrit, RBC, platelets, blood alcohol level
  • Ignoring or not understanding instructions for lung function testing
  • Body weight more than 160 kg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Medicine, University of Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

S

Stefan Kopf, MD

CONTACT

J

Jan B Groener, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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