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The Influence of Acute Hyperglycaemia on Brain in T1D

The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03188757
Enrollment
20
Registered
2017-06-15
Start date
2017-07-13
Completion date
2018-03-30
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Type 1 Diabetes Mellitus

Brief summary

The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20 years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and hyperglycaemic state. During both MRI, the participants are going to preform Flanker test, Tower of London test and Spatial memory test. The investigators are going to evaluate the response of inflammation markers and oxidative stress marekers in blood during hypreglycaemia.

Detailed description

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 .

Interventions

2h hyperglyceamic clamp

Sponsors

University of Ljubljana, Faculty of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* T1D on insulin pump, no diabetic complication, normal BMI and blood pressure

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
prolonged reaction timeduring the MRI in hyperglycaemia

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026