Beta Cell Function in (Pre) Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Beta Cell Function in (Pre) Type 1 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00800085
• Other study ID #: KD_BF_01
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: November 28, 2008
• Last updated: December 27, 2013
• Start date: October 2006
• Est. completion date: October 2015

Study information

• Verified date: December 2013
• Source: AZ-VUB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	UZ Brussels	Brussels
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
AZ-VUB

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. Erratum in: Diabetes. 2004 Apr;53(4):1175-6. — View Citation

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. Epub 2006 Mar 3. — View Citation

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. Epub 2002 Nov 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		48 months	No