The effect of lactate administration on cerebral blood flow during hypoglycemia
- Conditions
- Type 1 diabetes mellitus (T1DM)Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-000684-82-NL
- Lead Sponsor
- Radboud university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
-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: <160/90 mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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:
oProliferative retinopathy
oSymptomatic diabetic neuropathy (including autonomic neuropathy)
oNephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate <60ml/min/1.73m2
-MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>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. <br>;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 Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Global CBF: 15 minute inteval<br>Hormone levels: 1 time per glycemic phase<br>GIR: 5 minute inteval<br>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.<br>-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)<br>-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 <br>-Change in hypoglycemic symptoms scores in response to hypoglycemia with and without lactate infusion <br>