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Beta Cell Function in (Pre) Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bart Keymeulen, AZ-VUB
ClinicalTrials.gov Identifier:
NCT00800085
First received: November 28, 2008
Last updated: December 27, 2013
Last verified: December 2013

November 28, 2008
December 27, 2013
October 2006
October 2014   (final data collection date for primary outcome measure)
The systematic and simultaneous determination of markers of functional beta cell mass and immune status allows stratification according to the stage of the pathogenic process rather than according to a late metabolic consequence of this process [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Beta Cell Function in (Pre) Type 1 Diabetes
Beta Cell Function in (Pre) Type 1 Diabetes

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes. These criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints. This may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Type 1 Diabetes
Drug: 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
No Intervention: 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.
Intervention: Drug: glucose 20%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
October 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The following groups of first degree relatives of type1 diabetes patients with normal glucose tolerance during OGTT (5-39 years) will be included after informed consent on the basis of their antibody status (n = 40 per group):

    • 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:

  • Pregnancy or lactation in women
  • 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
Both
5 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00800085
KD_BF_01
No
Bart Keymeulen, AZ-VUB
AZ-VUB
Not Provided
Principal Investigator: katelijn Decochez, MD PhD UZ Brussels
AZ-VUB
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP