Type 1 diabetes mellitus (T1DM)
Conditions
Interventions
Trade Name: Sodium lactate
Product Name: sodium lactate
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diabetes duration = 1 year - Age: 18-50 years - Body-Mass Index: 18-30 kg/m2 - HbA1c: 42-75 mmol/mol (6-9%) - Outcome Clarke questionnaire: 0-1 - Blood pressure: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Inability to provide informed consent - Use medication other than insulin, except for oral contraceptives or stable thyroxin supplementation therapy - Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, or cardiac failure, known liver disease, anxiety disorders or a history of panic attacks. - Microvascular complications of T1DM: o Proliferative retinopathy o Symptomatic diabetic neuropathy (including autonomic neuropathy) o Nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate <60ml/min/1.73m2 - MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of intravenous lactate administration, compared to placebo, on thalamic (regional) CBF during euglycemia and hypoglycemia in patients with T1DM and normal awareness of hypoglycemia. ;Secondary Objective: To investigate the effect of intravenous lactate administration, compared to placebo, on global CBF during euglycemia and hypoglycemia in patients with T1DM and normal awareness of hypoglycemia. To assess changes in counterregulatory hormone and symptom responses to hypoglycemia in response to lactate infusion, compared to placebo, in patients with normal awareness of hypoglycemia. ;Primary end point(s): The main study parameter of the study is the change in regional thalamic CBF in response to intravenous lactate infusion compared to placebo, during hypoglycemia.;Timepoint(s) of evaluation of this end point: 15 minutes interval | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Global CBF: 15 minute inteval Hormone levels: 1 time per glycemic phase GIR: 5 minute inteval symptoms: beginning and end of glycemic phases;Secondary end point(s): - Change in global CBF in response to intravenous lactate infusion compared to placebo, during hypoglycemia. - Change in plasma levels of counterregulatory hormones in response to hypoglycemia and euglycemia with and without lactate infusion (adrenaline, noradrenaline, growth hormone and cortisol) (pmol/L, nmol/L, mU/L, µmol/L) - Change in glucose infusion rate (GIR): the amount of glucose 20% necessary to maintain plasma glucose at steady state euglycemic or hypoglycemic values (mg/kg/min) with and without lactate infusion - Change in hypoglycemic symptoms scores in response to hypoglycemia with and without lactate infusion | — |
Countries
Netherlands
Contacts
Public Contactclinical research centre nijmegen
Radboud umc
Outcome results
None listed