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The Influence of Acute Hyperglycaemia on Brain in T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03188757
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
Tadej Battelino, University of Ljubljana, Faculty of Medicine

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Type 1 Diabetes Mellitus Other: hyperglycaemic clamp Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: hyperglycaemic clamp Other: hyperglycaemic clamp
2h hyperglyceamic clamp

Primary Outcome Measures :
  1. prolonged reaction time [ Time Frame: during the MRI in hyperglycaemia ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

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 identifier (NCT number): NCT03188757

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Medical Faculty - University of Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tadej Battelino, prof. dr. Tadej Battelino, MD, University of Ljubljana, Faculty of Medicine Identifier: NCT03188757    
Other Study ID Numbers: Hyperglycemia-01
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases