The Influence of Acute Hyperglycaemia on Brain in T1D
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|ClinicalTrials.gov Identifier: NCT03188757|
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hyperglycemia Type 1 Diabetes Mellitus||Other: hyperglycaemic clamp||Not Applicable|
The study is going to include 20 patientswith T1D. The group of patients is going to be homogeneous. The inclusion criteria are going to be: duration of T1D approximately 5 - 10 years, age between 10 and 24 years, without associated clinical complications of T1D, similar value of HbA1c and BMI within the normal range (depending on the percentile for age and sex), treatment with an insulin pump. Only the patients who are going to give written consent to participate in the form "Declaration of conscious and free consent" are going to be included.
All selected clinical data to determine the phenotypic characteristics of the patient will be obtained from available medical records or. at their regular outpatient reading.
After 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp.
During hyperglycemia a sample of venous blood for the evaluation of oxidative stress, inflammatory response and the expression of non-coding RNA is going to be drawn.
Subjects will have 1H-MRS in hyperglycaemic and euglycaemic state and evaluation of executive function (using psychological tests) is going to be preformed. For 1H-MRS, the MRI of the head in order to obtain anatomical data is going to be preformed at first .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus|
|Actual Study Start Date :||July 13, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||March 30, 2018|
|Experimental: hyperglycaemic clamp||
Other: hyperglycaemic clamp
2h hyperglyceamic clamp
- prolonged reaction time [ Time Frame: during the MRI in hyperglycaemia ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188757
|Medical Faculty - University of Ljubljana|
|Ljubljana, Slovenia, 1000|