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
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes
Drug: glucose 20%
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Beta Cell Function in (Pre) Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by AZ-VUB:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2006
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800085

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
UZ Brussels
Brussels, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
AZ-VUB
Investigators
Principal Investigator: katelijn Decochez, MD PhD UZ Brussels
  More Information

Publications:

Responsible Party: Bart Keymeulen, MD PhD, AZ-VUB
ClinicalTrials.gov Identifier: NCT00800085     History of Changes
Other Study ID Numbers: KD_BF_01
Study First Received: November 28, 2008
Last Updated: December 27, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by AZ-VUB:
first degree relatives of type 1 diabetes patients
hyperglycemic clamp test

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014