The effect of hypoglycaemia on brain lactate accumulation and cerebral blood flow

The effect of insulin-induced hypoglycemia on brain lactate accumulation and regional cerebral blood flow in patients with type 1 diabetes mellitus with and without hypoglycemia unawareness and non-diabetic controls

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001777-13-NL

Enrollment

Registered

2014-06-03

Start date

2014-09-10

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Interventions

Trade Name: Insulin Aspart (Novorapid) Product Name: Novorapid Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy subjects - Age: 18-50 years - Body-Mass Index: 18-30 kg/m2 - Blood pressure: 3 - Blood pressure: =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. ;Secondary Objective: The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se.;Primary end point(s): The main study parameter is the concentration of lactate expressed both relative to the creatine concentration in the brain and quantitatively (mmol/L).;Timepoint(s) of evaluation of this end point: Brain lactate concentration will be measured at ~5 minutes interval	—

Measure

Time frame

Main Objective: The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. ;Secondary Objective: The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se.;Primary end point(s): The main study parameter is the concentration of lactate expressed both relative to the creatine concentration in the brain and quantitatively (mmol/L).;Timepoint(s) of evaluation of this end point: Brain lactate concentration will be measured at ~5 minutes interval

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Secondary

Measure	Time frame
Secondary end point(s): - Level of plasma counterregulatory hormones (glucagon, adrenaline, noradrenaline, growth hormone and cortisol) (pmol/L) - Glucose infusion rate (GIR): the amount of glucose 20% necessary to maintain plasma glucose at steady state euglycemic or hypoglycemic values (mg·kg-1·min-1) - Brain perfusion, determined by arterial spin labelling (ASL) MRI, measured twice (at stable euglycemic and hypoglycemic levels) (ml/min) - Hypoglycemic symptoms scores - Plasma lactate concentration (mmol/L) ;Timepoint(s) of evaluation of this end point: - GIR: 5 minutes interval -CBF: 1 time per glycemic phase - Hypoglycemic symptom score: every 30 minutes - Plasma lactate concentration: 5 minute interval	—

Measure

Time frame

Secondary end point(s): - Level of plasma counterregulatory hormones (glucagon, adrenaline, noradrenaline, growth hormone and cortisol) (pmol/L) - Glucose infusion rate (GIR): the amount of glucose 20% necessary to maintain plasma glucose at steady state euglycemic or hypoglycemic values (mg·kg-1·min-1) - Brain perfusion, determined by arterial spin labelling (ASL) MRI, measured twice (at stable euglycemic and hypoglycemic levels) (ml/min) - Hypoglycemic symptoms scores - Plasma lactate concentration (mmol/L) ;Timepoint(s) of evaluation of this end point: - GIR: 5 minutes interval -CBF: 1 time per glycemic phase - Hypoglycemic symptom score: every 30 minutes - Plasma lactate concentration: 5 minute interval

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Countries

Netherlands

Contacts

Public ContactClinical research centre nijmegen

Radboud umc

crcn@crcn.umc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026