Diabetes Type 1 Diabetes Mellitus
Conditions
Interventions
In random order, subjects will undergo a hyperinsulinemic hypoglycemic glucose
(nadir, 2.5 mmol/l) clamp after either a short high intensity training to raise
plasma lactate levels (intervention) or
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age: 18-40 years BMI: 18-30 kg/m2 blood pressure 1year HbA1c: 42-75 mmol/mol (6-9%) Outcome clarke questionnaire: 0-1 (normal awareness) or >=3 (hypoglycemia unawareness)
Exclusion criteria
Exclusion criteria: - Inability to provide informed consent - Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders - Use of any medication, except for oral contraceptives - For the MR study: MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body) - Orthopedic and/or neurological diseases that impair exercise - Cardiopulmonary disease ;For T1DM subjects: - complications of T1DM, e.g. proliferative retinopathy, neuropathy or overt/clinical albuminuria - Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the plasma adrenaline response to hypoglycemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are levels of other plasma counterregulatory hormones, hypoglycemic symptom scores and cognitive functioning during hypoglycemia and the levels of inflammatory markers/cytokines. In addition we will measure brain lactate accumulation and brain perfusion after exercise in a subset of patients. | — |
Countries
Netherlands
Outcome results
None listed