Beta Cell Function in (Pre) Type 1 Diabetes

NCT00800085 | Unknown Phase 1

• 1 other identifier: KD_BF_01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

first degree relatives of type 1 diabetes patients; hyperglycemic clamp test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

FDR of type 1 diabetes patients receiving glucose 20%

NO INTERVENTION

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%

Interventions

glucose 20% DRUG

maintain glycemia at 180 mg/dL till 150 min. after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals

FDR of type 1 diabetes patients receiving glucose 20%

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ-VUB: lead

Study Sites (4)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

UZ Brussels

Brussels, 1090, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (6)

• 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.

  PMID: 382871 BACKGROUND

• 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.

  PMID: 9028724 BACKGROUND

• 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.

  PMID: 12488955 BACKGROUND

• 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.

  PMID: 14747289 BACKGROUND

• 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.

  PMID: 16514546 BACKGROUND

• 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.

  PMID: 10330299 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• katelijn Decochez, MD PhD

  UZ Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: October 1, 2006
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

BE (4)