|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03188757 |
|
Date of registration:
|
13/06/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Influence of Acute Hyperglycaemia on Brain in T1D
|
|
Scientific title:
|
The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus |
|
Date of first enrolment:
|
July 13, 2017 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03188757 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- T1D on insulin pump, no diabetic complication, normal BMI and blood pressure
Exclusion Criteria:
-
Age minimum:
12 Years
Age maximum:
20 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hyperglycemia
|
|
Type 1 Diabetes Mellitus
|
|
Intervention(s)
|
|
Other: hyperglycaemic clamp
|
|
Primary Outcome(s)
|
|
prolonged reaction time
[Time Frame: during the MRI in hyperglycaemia]
|
|
Secondary ID(s)
|
|
Hyperglycemia-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|