Hypoglycemia associated autonomic failure, diabetes mellitus
Conditions
Interventions
Group 1: Diabetes patients with hypoglycemic unawareness are evaluated for adrenergic regulation in hypoglycemia using a single hyperinsulinemic hypoglycemic clamptest. In addition, testing for neurop
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects without hypoglycemia awareness disorder: BMI between 20 and 40 kg/m2, individuals with manifest diabetes mellitus type 1 or type 2 and confirmed diagnosis according to 2011 DDG criteria (i.e., HbA1c = 6.5% with exclusion of alterations of HbA1c, above 200 mg/dl in 2-hour value of oGTT, pathological fasting glucose above 126 mg/dl, at least twice pathological spontaneous glucose of = 200 mg/dl), ability to consent. Inclusion criteria for subjects with hypoglycemia awareness disorder: Individuals who do not perceive hypoglycemic symptoms up to glucose levels of 50 mg/dl, BMI between 20 and 40 kg/m2, individuals with manifest diabetes mellitus type 1 or type 2 and confirmed diagnosis according to 2011 DDG criteria (i.e., HbA1c = 6.5% with exclusion of alterations of HbA1c, above 200 mg/dl in 2-hour value of oGTT, pathological fasting glucose above 126 mg/dl, at least twice pathological spontaneous glucose of = 200 mg/dl), ability to consent.
Exclusion criteria
Exclusion criteria: Secondary forms of diabetes (ADA criteria type 3 B-H), current pregnancy, acute infections/fever, immunosuppressive therapy, known severe psychiatric illness requiring treatment (e.g., personality disorders, schizophrenia, depression), known dependence on alcohol or other drugs, severe cardiac, renal, or hepatic disease: NYHA stage IV, known non-diabetic liver disease (e.g., PBC, PSC, Wilson's disease, hemochromatosis, autoimmune hepatitis), severe pAVK (stage IV), known nondiabetic glomerulopathy, known malignant cancer in the past 5 years, known infectious hepatitis B, C, E, HIV, known other autoimmune disease, current participation in an intervention trial, known anemia or bone marrow disorder Exclusion criteria for clamp testing: history of thrombosis or peripheral pulmonary artery embolism, routine laboratory clinical chemistry values: = 80% of lower reference value: ferritin, iron, leukocytes, Hb, Hkt, erythrocytes, platelets, (residual) blood alcohol detection [‰].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlate metabolic signatures of patients with impaired hypoglycemia awareness (HAAF). | — |
Countries
Germany
Contacts
Public ContactAlba Sulaj
Universitätsklinikum Heidelberg
Outcome results
None listed