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Status:

COMPLETED

Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives

Lead Sponsor:

AZ-VUB

Collaborating Sponsors:

Novo Nordisk A/S

Conditions:

Diabetes, Type I

Eligibility:

All Genders

5-39 years

Phase:

PHASE2

Brief Summary

Prophylactic administration of metabolically active insulin can prevent or delay clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for autoantibodies aga...

Detailed Description

Hypotheses: Primary: Prophylactic administration of metabolically active insulin can prevent or delay clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity ...

Eligibility Criteria

Inclusion

  • Sibling/offspring of a Type 1 diabetic patient
  • in good general condition
  • age 5-39 years
  • fasting plasma glucose \<126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33):
  • Normal glycemia:
  • fasting plasma glucose \< 110 mg/dL and
  • 2 hour plasma glucose \< 140 mg/dL
  • Impaired Fasting Glucose (IFG):
  • fasting plasma glucose 110-125 mg/dL and
  • 2 hour plasma glucose \< 140 mg/dL
  • Impaired Glucose Tolerance (IGT):
  • fasting plasma glucose \<110 mg/dL and
  • 2 hour plasma glucose 140-199 mg/dL
  • at least positive for IA-2-A
  • absence of a protective DQ genotype: A4-B2/X or X/Y or X/X where X = A2-B3.3, A1-B1.9, A1-B1.2, A4-B3.1, A2-B2 or A4.23-B3.1 Y = A1-B1.1, A1-B2, A1-B1.AZH, A3-B2, A3-B3.1, A3-B3.3, A3-B4, A4-B4, A4.23-B4, A4-B3.2, A3-B1.1, A4-B3.3, A4-B1.1 or A4.23-B2 (32)
  • cooperative and reliable subject (age ≥ 14 yrs) / parents (age \< 14 yrs) giving informed consent by signature; the patient/parents should be informed in sufficient detail on the content and procedure of the protocol, indicating potential risks of insulin therapy; early intervention with metabolically active insulin treatment should be identified as a clinical trial. Both parents should sign and agree with the protocol procedure.

Exclusion

  • diabetes by 1997 ADA criteria (33):
  • fasting plasma glucose ≥ 126 mg/dL, or
  • 2 hour plasma glucose ≥ 200 mg/dL
  • donation of blood during the study or within one month prior to screening
  • pregnancy or lactation in women
  • use of inadequate anticonception by female patients of childbearing potential
  • 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 or having done so during the last 12 months
  • history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient

Key Trial Info

Start Date :

February 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2007

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT00654121

Start Date

February 1 2000

End Date

November 1 2007

Last Update

April 7 2008

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

2

Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, Belgium, 1090

3

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

Leuven, Belgium, 3000