Type1diabetes Clinical Trial
Official title:
The Effect of Lactate Administration on Cerebral Blood Flow During Hypoglycemia; Are the Suppressive Effects of Lactate on Counterregulatory Responses to Hypoglycemia Reflected in an Altered CBF Response?
It is thought that altered brain lactate handling is involved in the development of impaired
awareness of hypoglycemia (IAH), i.e. the inability to timely detect hypoglycemia in people
with type 1 diabetes (T1DM). Infusion of lactate diminishes symptomatic and hormonal
responses to hypoglycemia in patients with normal awareness of hypoglycemia (NAH), resembling
the situation of patients with IAH. It is unknown whether this attenuating effect is due to
brain lactate oxidation or the result of lactate-induced alterations of global and regional
cerebral blood flow (CBF).
Normally, hypoglycemia causes a redistribution of CBF towards the thalamus, from where the
sympathetic response to hypoglycemia is coordinated, but in IAH this effect is absent and
global CBF is increased. We hypothesize that lactate infusion in patients with NAH will
result in blunting of thalamic activation and/or enhanced global CBF. If so, these results
may help delineating the pathogenesis of IAH which eventually creates new avenues to protect
against the morbidity associated with hypoglycemia and IAH.
Study design: Single-blind placebo controlled, randomized cross-over intervention study Study
population: T1DM patients with NAH (n=10) Intervention: On two separate occasions, patients
with T1DM and NAH will undergo a hyperinsulinemic euglycemic-hypoglycemic glucose clamp with
or without the infusion of exogenous lactate. ASL-MRI will be applied to measure global and
regional changes in CBF.
Main study parameters/endpoints: The change in regional thalamic CBF in response to
intravenous lactate infusion compared to placebo, during hypoglycemia
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03886974 -
Transition to Adult Care in Type 1 Diabetes
|
||
| Completed |
NCT05620251 -
Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
|
||
| Completed |
NCT03623113 -
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05078658 -
Low-carbohydrate Diet in Children With Type 1 Diabetes
|
N/A | |
| Not yet recruiting |
NCT06018324 -
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
|
||
| Withdrawn |
NCT03736083 -
Introducing CGM at Type 1 Diabetes Diagnosis
|
N/A | |
| Completed |
NCT03177096 -
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes
|
N/A | |
| Completed |
NCT04172077 -
Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
|
||
| Recruiting |
NCT04950634 -
Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
|
||
| Completed |
NCT04450745 -
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
|
N/A | |
| Completed |
NCT03165786 -
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
|
N/A | |
| Terminated |
NCT04028960 -
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
|
Phase 2 | |
| Recruiting |
NCT05324488 -
Diabetes Registry Graz for Biomarker Research
|
||
| Completed |
NCT02984709 -
Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes
|
N/A | |
| Completed |
NCT02984514 -
Brown Adipose Tissue in Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05973799 -
Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT03311516 -
New Insulin Therapy by Multiwave Bolus
|
N/A | |
| Completed |
NCT03711656 -
Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques
|
N/A | |
| Recruiting |
NCT05737654 -
The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life
|
N/A | |
| Completed |
NCT05044442 -
HIT on Hypoglycaemic Risk in T1D
|
N/A |