| Trial ID: | L5663 |
| Source ID: | NCT01402037
|
| Associated Drug: |
Glucose
|
| Title: |
Beta Cell Function in (Pre)Type 1 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Glucose|DEVICE: Continuous glucose monitoring
|
| Outcome Measures: |
Primary: evaluate the hyperglycemic clamp to measure the functional beta cell mass test, to measure the functional beta cell mass of participants as determined by AUC C-peptide release during hyperglycemic clamp test, 2 years | Secondary: Follow up of OGTT's and HbA1c levels in high risk first degree relatives and patients, 2) perform oral glucose tolerance tests (OGTTs; only in relatives), determine HbA1c levels centrally (relatives and patients) and record insulin requirements and hypoglycemic episodes (in patients), 2 years|evaluate the continuous glucose monitoring to measure within- and between-day glycemic variability, to measure within- and between-day glycemic variability as determined by seven point selfmonitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) during 5 days preceding each clamp procedure, 2 years
|
| Sponsor/Collaborators: |
Sponsor: AZ-VUB | Collaborators: Vrije Universiteit Brussel|University Hospital, Ghent|University Hospital, Antwerp
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2011-07
|
| Completion Date: |
2016-07
|
| Results First Posted: |
|
| Last Update Posted: |
2013-12-30
|
| Locations: |
UZ Brussels, Brussels, 1090, Belgium|UZ Antwerpen, Edegem, 2650, Belgium|UZ Gent, Gent, 9000, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT01402037
|
