The effect of lactate administration on cerebral blood flow during hypoglycemia

Completed

Conditions: diabetes
Diabetes Mellitus
10018424

Registration Number: NL-OMON48795

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Diabetes duration * 1 year
- Age: 18-50 years
- Body-Mass Index: 18-30 kg/m2
- HbA1c: <75 mmol/mol (<9%)
- Outcome Clarke questionnaire: 0-1
- Blood pressure: <160/90 mmHg

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
- MRI contraindications (pregnancy, severe claustrophobia, metal parts in body)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in regional thalamic CBF in response to intravenous lactate infusion<br /><br>compared to placebo, during hypoglycemia</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in global CBF in response to intravenous lactate infusion compared to<br /><br>placebo, during hypoglycemia<br /><br>- Change in plasma levels of counterregulatory hormones in response to<br /><br>hypoglycemia and euglycemia with and without lactate infusion (adrenaline,<br /><br>noradrenaline, growth hormone and cortisol)<br /><br>- Change in hypoglycemic symptoms scores in response to hypoglycemia with and<br /><br>without lactate infusion </p><br>