CompletedNot Applicable

The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow

Netherlands21 participantsStarted 2014-08

Plain-language summary

Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen consumption and cerebral blood flow. 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. The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se. Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical hypoglycemia unawareness. Furthermore, the investigators expect that this effect of hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow (CBF).

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 cl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain lactate concentration

Timeframe: during stable euglycemia and hypoglyemia

Trial details

NCT IDNCT02146404

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials