Status:
COMPLETED
Glucose-dependent Asprosin Dynamics
Lead Sponsor:
Heidelberg University
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Brief Summary
The study entitled " Asprosin Dynamics relating to serum Glucose levels under controlled alterations" investigates the dynamics of Asprosin in relation to glucose levels under controlled conditions in...
Detailed Description
The Pilot study entitled Asprosin Dynamics relating to serum Glucose levels under controlled alterations is designed to date the asprosin kinetics at various metabolic states relating to serum glucose...
Eligibility Criteria
Inclusion
- Inclusion criteria for participants without hypoglycemia unawareness
- Age between 18 and 75 years
- BMI between 20 und 35 kg per m2
- Persons with manifest diabetes mellitus type 1 and diagnosis according to according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice.
- Inclusion criteria for participants without hypoglycemia unawareness
- Persons who are not aware of hypoglycemia symptoms at glucose levels above 50 mg per dl
- Age between 18 and 75 years
- BMI between 20 und 35 kg per m2
- Persons with manifest diabetes mellitus type 1 and diagnosis according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice.
- General exclusion criteria Secondary types of diabetes (ADA criteria type 3 B to H)
- Current pregnancy
- Acute infections or fever Immune-suppressant therapy
- Severe psychiatric diseases requiring treatment (for example personality disorders, schizophrenia, depression)
- Known alcohol or drug dependency
- Severe heart, kidney, or liver insufficiency NYHA stadium IV
- Non-diabetic liver disease (for example PBC, PSC, Wilson's 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 clamp study
- Past history of deep vein thrombosis or pulmonary embolism
- Routine laboratory test results less than 80 percent below lower reference value: Ferritin, iron, leucocytes, haemoglobin, hematocrit, RBC, platelets, blood alcohol levels.
- Exclusion criteria for bioimpedance
- measurement Pacemaker or ICD
- Exclusion criteria for lung function testing Ignoring or non-understanding of the instructions
Exclusion
Key Trial Info
Start Date :
July 11 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03358121
Start Date
July 11 2017
End Date
October 13 2017
Last Update
November 30 2017
Active Locations (1)
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1
Medizinische Klinik, University Hospital
Heidelberg, Baden-Wurttemberg, Germany, 60120