Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2006-10-31
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FDR of type 1 diabetes patients receiving glucose 20%
First Degree Relatives of diabetes type 1 patient with a high, intermedian or low risk (accoring to the criteria of the protocol), for developing diabetes type 1.
glucose 20%
maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
glucose 20%
maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* IA-2A-positives;
* Ab.-positives (positive for at least 2 different Abs. (IAA, GADA and/or ICA) and/or persistently Ab.-positive for 1 of these Abs;
* persistently Ab.-negatives.
* 40 type 1 diabetes patients with the following criteria will be studied: 1) aged 12-39 years; 2) \< 4 weeks of insulin treatment; 3) auto-Ab.-positive; 4) polyuria since \< 6 months; 5) \< 10% weight loss over the last 6 months; 6) informed consent.
Exclusion Criteria
* Use of illicit drugs or overconsumption of alcohol (\> 3 beers/day) 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)
* Presently participating in another clinical study
* 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
5 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AZ-VUB
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bart Keymeulen
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
katelijn Decochez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Brussels
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
UZ Brussels
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
Gorus FK, Goubert P, Semakula C, Vandewalle CL, De Schepper J, Scheen A, Christie MR, Pipeleers DG. IA-2-autoantibodies complement GAD65-autoantibodies in new-onset IDDM patients and help predict impending diabetes in their siblings. The Belgian Diabetes Registry. Diabetologia. 1997 Jan;40(1):95-9. doi: 10.1007/s001250050648.
Decochez K, De Leeuw IH, Keymeulen B, Mathieu C, Rottiers R, Weets I, Vandemeulebroucke E, Truyen I, Kaufman L, Schuit FC, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. IA-2 autoantibodies predict impending type I diabetes in siblings of patients. Diabetologia. 2002 Dec;45(12):1658-66. doi: 10.1007/s00125-002-0949-8. Epub 2002 Nov 12.
Achenbach P, Warncke K, Reiter J, Naserke HE, Williams AJ, Bingley PJ, Bonifacio E, Ziegler AG. Stratification of type 1 diabetes risk on the basis of islet autoantibody characteristics. Diabetes. 2004 Feb;53(2):384-92. doi: 10.2337/diabetes.53.2.384.
Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. Progression to type 1 diabetes in islet cell antibody-positive relatives in the European Nicotinamide Diabetes Intervention Trial: the role of additional immune, genetic and metabolic markers of risk. Diabetologia. 2006 May;49(5):881-90. doi: 10.1007/s00125-006-0160-4. Epub 2006 Mar 3.
Maclaren N, Lan M, Coutant R, Schatz D, Silverstein J, Muir A, Clare-Salzer M, She JX, Malone J, Crockett S, Schwartz S, Quattrin T, DeSilva M, Vander Vegt P, Notkins A, Krischer J. Only multiple autoantibodies to islet cells (ICA), insulin, GAD65, IA-2 and IA-2beta predict immune-mediated (Type 1) diabetes in relatives. J Autoimmun. 1999 Jun;12(4):279-87. doi: 10.1006/jaut.1999.0281.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KD_BF_01
Identifier Type: -
Identifier Source: org_study_id