Back to resultsThe Influence of Acute Hyperglycaemia on Brain in T1D
Primary Purpose
Hyperglycemia, Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
hyperglycaemic clamp
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- T1D on insulin pump, no diabetic complication, normal BMI and blood pressure
Exclusion Criteria:
-
Sites / Locations
- Medical Faculty - University of Ljubljana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hyperglycaemic clamp
Arm Description
Outcomes
Primary Outcome Measures
prolonged reaction time
Secondary Outcome Measures
Full Information
NCT ID
NCT03188757
First Posted
June 13, 2017
Last Updated
May 8, 2018
Sponsor
University of Ljubljana, Faculty of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03188757
Brief Title
The Influence of Acute Hyperglycaemia on Brain in T1D
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ljubljana, Faculty of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyperglycaemic clamp
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
hyperglycaemic clamp
Intervention Description
2h hyperglyceamic clamp
Primary Outcome Measure Information:
Title
prolonged reaction time
Time Frame
during the MRI in hyperglycaemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1D on insulin pump, no diabetic complication, normal BMI and blood pressure
Exclusion Criteria:
-
Facility Information:
Facility Name
Medical Faculty - University of Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32471909
Citation
Suput Omladic J, Slana Ozimic A, Vovk A, Suput D, Repovs G, Dovc K, Bratina N, Avbelj Stefanija M, Battelino T. Acute Hyperglycemia and Spatial Working Memory in Adolescents With Type 1 Diabetes. Diabetes Care. 2020 Aug;43(8):1941-1944. doi: 10.2337/dc20-0171. Epub 2020 May 29.
Results Reference
derived
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The Influence of Acute Hyperglycaemia on Brain in T1D
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