- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188757
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
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Medical Faculty - University of Ljubljana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- T1D on insulin pump, no diabetic complication, normal BMI and blood pressure
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hyperglycaemic clamp
|
2h hyperglyceamic clamp
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
prolonged reaction time
Time Frame: during the MRI in hyperglycaemia
|
during the MRI in hyperglycaemia
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hyperglycemia-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia
-
Mayo ClinicCompletedHospital Hyperglycemia | Post-transplant HyperglycemiaUnited States
-
Zealand University HospitalNot yet recruitingStress Hyperglycemia | Postoperative Hyperglycemia
-
University of CopenhagenUnknownSurgery--Complications | Hyperglycemia Stress | Hyperglycemia Steroid-inducedDenmark
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...RecruitingHyperglycemia StressUnited States
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Centre Hospitalier Universitaire de BesanconEli Lilly and Company; AstraZenecaCompleted
-
Medical University of ViennaCompleted
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
Clinical Trials on hyperglycaemic clamp
-
Steno Diabetes Center CopenhagenUniversity of CopenhagenCompletedType 2 Diabetes | Maturity-Onset Diabetes of the Young, Type 3Denmark
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of Illinois College of Medicine at PeoriaOSF Healthcare SystemUnknown
-
Albert Einstein College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes | Malnutrition; Diabetes
-
TriHealth Inc.CompletedCircumcision, MaleUnited States
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingRenal Cell CarcinomaRussian Federation
-
Brigham and Women's HospitalBeth Israel Deaconess Medical Center; Boston Children's Hospital; Mclean HospitalRecruitingHypoglycemia | Physiological StressUnited States
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedType 1 Diabetes MellitusUnited States