NCT03188757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

June 13, 2017

Last Update Submit

May 8, 2018

Conditions

HyperglycemiaType 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • prolonged reaction time

    during the MRI in hyperglycaemia

Study Arms (1)

hyperglycaemic clamp

EXPERIMENTAL
Other: hyperglycaemic clamp

Interventions

hyperglycaemic clampOTHER

2h hyperglyceamic clamp

hyperglycaemic clamp

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty - University of Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 32471909DERIVED

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr. Tadej Battelino, MD

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

July 13, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

SL(1)