Clinical trial NCT01429467: Glucose Variability in Type 1 Diabetes and Its Effect on Factors That Influence New Vessel Formation
Official title: Improving Glucose Variability in Type 1 Diabetes and Its Effect on the Underlying Homeostatic Metabolic Pathways of Angiogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Glucose Variability
Continuous Glucose Monitoring
Hypoxia-inducible Factor (HIF)
Vascular Endothelial Growth Factor (VEGF)
Erythropoietin
Cortisol
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to see how glycaemic control and glycaemic variability affect levels of HIF, VEGF, erythropoietin and cortisol in Paediatric Type 1 diabetics on insulin pump therapy.

Detailed description: The study will have two parts. The first phase will look at all current paediatric type 1 diabetics in Tayside on continuous subcutaneous insulin pump therapy and measure their levels of Hypoxia-Inducible Factor (HIF), Vascular Endothelial Growth Factor (VEGF), erythropoietin and cortisol. This will help answer the question; Does glucose control (as expressed by HbA1c ) effect levels of HIF, VEGF, erythropoietin and cortisol? To our knowledge this will be the first human study comparing how HIF, VEGF, erythropoietin and cortisol are affected by glucose control

The second phase of the trial will chose 10 patients on insulin pump therapy and using a continuous glucose monitor (CGM), monitor their glucose variability over a period of 6 weeks. After this period their levels of HIF, VEGF, erythropoietin and cortisol will again be measured. This will help answer the question of whether there is a relationship between glucose variability and levels of HIF, VEGF, erythropoietin and cortisol. As we know that these factors are stimulated by episodes of hypo and hyperglycaemia, it is hypothesised that these factors will be lower in participants that demonstrate reduced glucose variability. It will be the first study to give detailed information on the relationship between HIF, VEGF, erythropoietin and cortisol and glucose variability.

By using telemedicine sessions during weeks 1, 3 and 5 of the participants wearing CGM we will aim to improve the participant's glucose variability. This will help give further information about glucose variability and the above factors as well as giving further evidence for the use of telemedicine and CGM to improve glycaemic control in adolescent diabetics.

Eligibility criteria: Inclusion Criteria:

Phase 1 inclusion:

* Patients with Type 1 Diabetes
* On insulin pump therapy.
* Aged 5 years to 18 years.

Phase 2 inclusion:

* Patents with Type 1 Diabetes
* Diabetes diagnosis for 1 year
* On insulin pump therapy for minimum of six months
* Access to a computer with internet access and telephone
* Agree to wear CGM for 6 weeks
* Aged 12 years to 18 years

Exclusion Criteria:

* Patients not on pump therapy
* Patient less than 5 years and greater than 18 years
* Phase 2 patients been on pump therapy for less than 6 months
* Phase 2 patients without access to internet and telephone.
* Phase 2 patients less than 12 years and greater than 18 years
* Patients who do not have a good understanding of English

Primary outcomes:
measure: Correlation of HbA1c and level of Hypoxia-inducible Factor
timeFrame: Baseline
measure: Correlation of HbA1c and level of Vascular Endothelial Growth Factor
timeFrame: Baseline
measure: Correlation of HbA1c and level of Erythropoietin
timeFrame: Baseline
measure: Correlation of HbA1c and level of cortisol
timeFrame: Baseline
Secondary outcomes:
measure: Change in Mean Area of Glucose Excursion (MAGE) following CGM
timeFrame: 6 weeks
measure: Change in levels of Hypoxia-inducible factor following CGM
timeFrame: 6 weeks
measure: Change in levels of Vascular Endothelial Growth Factor following CGM
timeFrame: 6 weeks
measure: Change in levels of erythropoietin following CGM
timeFrame: 6 weeks
measure: Change in levels of cortisol following CGM
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University Of Dundee
state: Angus
Study officials:
affiliation: University of Dundee
name: Anthony PB Tasker, MBChB
role: PRINCIPAL_INVESTIGATOR
References: