Status:
COMPLETED
The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Diabetes Research Foundation
European Foundation for the Study of Diabetes
Conditions:
Type 1 Diabetes Mellitus With Hypoglycemia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia, referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe hypoglycemia. IAH aff...
Eligibility Criteria
Inclusion
- 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 or \>=3
- Blood pressure: \<160/90 mmHg
Exclusion
- 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, known liver disease, anxiety disorders or a history of panic attacks.
- Microvascular complications of T1DM: Proliferative retinopathy, Symptomatic diabetic neuropathy (including autonomic neuropathy), Nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate \<60ml/min/1.73m2
- MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03286816
Start Date
November 1 2016
End Date
August 1 2017
Last Update
September 19 2017
Active Locations (1)
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1
Radboud umc
Nijmegen, Netherlands