Status:
UNKNOWN
Beta Cell Function in (Pre)Type 1 Diabetes
Lead Sponsor:
AZ-VUB
Collaborating Sponsors:
Vrije Universiteit Brussel
University Hospital, Ghent
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
5-39 years
Phase:
NA
Brief Summary
Increased glycemic variability has been proposed as an independent predictor of hypoglycemia in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of diabetes in ant...
Detailed Description
The established clinical network and the developed dynamic function tests and biological markers provide us with the unique opportunity to identify sufficiently large groups of high-risk first-degree ...
Eligibility Criteria
Inclusion
- Type 1 diabetic patients:
- aged 12-39 years at diagnosis
- treated with insulin for less than 4 weeks
- optimally treated with intensified insulin treatment: minimal three preprandial injections of ultra-rapidly acting analogs and one evening injection of long-acting insulin (Lantus®, Sanofi Aventis)
- positive for autoantibodies against insulin (IAA-sampled within the first week of insulin treatment), 65kDa glutamate decarboxylase (GADA), IA-2 protein (IA-2A) and/or zinc transporter 8 (ZnT8A)
- First-degree relatives:
- aged 12-39 years at inclusion
- sibling or offspring of a type 1 diabetic patient diagnosed before age 35 or between age 35 and 50 with in addition a body mass index \< 28 kg/m2 and an initial insulin dose \> 0.25 U.kg -1.d-1
- \> 50% risk of diabetes within 5 years as indicated by positivity for at least 2 diabetes antibodies including IA-2A and/or ZnT8A in absence of protective HLA-DQ genotypes (6)
Exclusion
- pregnancy or lactation in women
- use of illicit drugs or overconsumption of alcohol or history of drug or alcohol abuse
- being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
- having received antidepressant medications during the last 6 months
- treatment with immune modulating or diabetogenic medication (such as corticosteroids)
- history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects
- patients not treated with Lantus as insulin therapy.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01402037
Start Date
July 1 2011
End Date
July 1 2016
Last Update
December 30 2013
Active Locations (3)
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1
UZ Brussels
Brussels, Belgium, 1090
2
UZ Antwerpen
Edegem, Belgium, 2650
3
UZ Gent
Ghent, Belgium, 9000