| Trial ID: | L3400 |
| Source ID: | NCT03286816
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| Associated Drug: |
Sodiumchloride
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| Title: |
The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus With Hypoglycemia
|
| Interventions: |
DRUG: SodiumChloride|DRUG: Sodium Lactate
|
| Outcome Measures: |
Primary: the effect of intravenous lactate administration, compared to placebo, on brain lactate concentrations during euglycemia and hypoglycemia in patients with T1DM and normal awareness of hypoglycemia, during stable euglycemia (40 min) and hypoglycemia (45 min)|the effect of exogenous lactate on brain lactate concentrations during euglycemia and hypoglycemia between T1DM patients with normal awareness of hypoglycemia and T1DM patients with impaired awareness of hypoglycemia, during stable euglycemia (40 min) and hypoglycemia (45 min) | Secondary: The changes in counterregulatory hormone and to hypoglycemia in response to lactate infusion, compared to placebo, in patients with normal awareness of hypoglycemia, during stable euglycemia (40 min) and hypoglycemia (45 min)|The changes in and symptoms to hypoglycemia in response to lactate infusion, compared to placebo, in patients with normal awareness of hypoglycemia, during stable euglycemia (40 min) and hypoglycemia (45 min)|The changes in brain pH in response to intravenous lactate administration, compared to placebo, during stable euglycemia (40 min) and hypoglycemia (45 min)|Changes in immune cell composition capacity in response to hypoglycemia compared to euglycemia and in response to lactate infusion compared to placebo, during stable euglycemia (40 min) and hypoglycemia (45 min)|Changes in immune cell cytokine production capacity in response to hypoglycemia compared to euglycemia and in response to lactate infusion compared to placebo, during stable euglycemia (40 min) and hypoglycemia (45 min)
|
| Sponsor/Collaborators: |
Sponsor: Radboud University Medical Center | Collaborators: Dutch Diabetes Research Foundation|European Foundation for the Study of Diabetes
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| Gender: |
ALL
|
| Age: |
ADULT
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| Phases: |
|
| Enrollment: |
19
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2016-11
|
| Completion Date: |
2017-08
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| Results First Posted: |
|
| Last Update Posted: |
2017-09-19
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| Locations: |
Radboud umc, Nijmegen, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT03286816
|
