The Influence of Acute Hyperglycaemia on Brain in T1D

NCT ID: NCT03188757

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2018-03-30

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 .

Conditions

Hyperglycemia; Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hyperglycaemic clamp

Group Type: EXPERIMENTAL

hyperglycaemic clamp

Intervention Type: OTHER

2h hyperglyceamic clamp

Interventions

hyperglycaemic clamp

2h hyperglyceamic clamp

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Tadej Battelino

prof. dr. Tadej Battelino, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Faculty - University of Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

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.

Reference Type: DERIVED

PMID: 32471909 (View on PubMed)

Other Identifiers

Hyperglycemia-01

Identifier Type: -

Identifier Source: org_study_id