The effect of insulin-induced hypoglycemia on brain lactate accumulation and regional cerebral blood flow, an explorative study

Completed

• Conditions: Diabetes; Diabetes Mellitus; 10018424

• Registration Number: NL-OMON40939
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-06-01
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

Inclusion criteria for healthy subjects;
- Age: 18-50 years
- Body-Mass Index: 18-30 kg/m2
- Blood pressure: <160/90 mmHg;Inclusion criteria T1DM patients with normal hypoglycemic awareness
- 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;Inclusion criteria T1DM patients with hypoglycemia unawareness
- 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:>3
- Blood pressure: <160/90 mmHg

Exclusion Criteria

Exclusion criteria for healthy subjects;- 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;- MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body);Exclusion criteria for all T1DM patients;- Inability to provide informed consent;- Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, anxiety disorders, or complications of T1DM (including neuropathy and retinopathy);- Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy;- MR(I) 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 main study parameter is the concentration of lactate in the brain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be:<br /><br>- Level of plasma counterregulatory hormones (glucagon, adrenaline,<br /><br>noradrenaline, growth hormone and cortisol) (pmol/L)<br /><br>- Glucose infusion rate (GIR): the amount of glucose 20% necessary to maintain<br /><br>plasma glucose at steady state euglycemic or hypoglycemic values (mg*kg-1*min-1)<br /><br>- Brain perfusion, determined by arterial spin labelling (ASL) MRI, measured<br /><br>twice (at stable euglycemic and hypoglycemic levels) (ml/min)<br /><br>- Hypoglycemic symptoms scores<br /><br>- Plasma lactate concentration (mmol/L)<br /><br><br /><br>Other study parameters<br /><br>- Plasma glucose concentration (mmol/L)<br /><br>- Plasma insulin concentration (pmol/L)</p><br>