- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654121
Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives
Prevention of Clinical Onset of Type 1 Diabetes by Daily Administration of Metabolically Active Insulin in High Risk First Degree Relatives.
Study Overview
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 for autoantibodies against IA-2 (IA-2-A).
Secondary: 1) Untreated siblings with positivity for IA-2-A develop clinical diabetes significantly faster than untreated offspring with the same marker positivity. 2) Plasma proinsulin levels increase disproportionately before clinical onset of Type 1 diabetes both in siblings and offspring. 3) Prophylactic administration of metabolically active insulin reduces the plasma proinsulin/C-peptide ratio in non-diabetic antibody positive siblings and offspring. 4) Prophylactic administration of metabolically active insulin reduces the presence and/or levels of diabetes-associated autoantibodies directed against islet cell components.
Endpoints: Fasting glycemia; fasting and stimulated plasma C-peptide and proinsulin values; islet cell autoantibodies; incidence of hypoglycemia; body weight gain.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Antwerpen, Belgium
- Universitair Ziekenhuis Antwerpen
-
Brussels, Belgium, 1090
- Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
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Leuven, Belgium, 3000
- Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
|
Active Comparator: 1
56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
|
56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting glycemia;
Time Frame: 2004
|
2004
|
fasting and stimulated plasma C-peptide and proinsulin values;
Time Frame: 2004
|
2004
|
islet cell autoantibodies;
Time Frame: 2004
|
2004
|
body weight gain.
Time Frame: 2004
|
2004
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frans Gorus, MD,PhD, Universitair Ziekenhuis Brussel
- Principal Investigator: Evy Vandemeulebroucke, MD, Universitair Ziekenhuis Brussel
Publications and helpful links
General Publications
- Decochez K, Truyen I, van der Auwera B, Weets I, Vandemeulebroucke E, de Leeuw IH, Keymeulen B, Mathieu C, Rottiers R, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. Combined positivity for HLA DQ2/DQ8 and IA-2 antibodies defines population at high risk of developing type 1 diabetes. Diabetologia. 2005 Apr;48(4):687-94. doi: 10.1007/s00125-005-1702-x. Epub 2005 Mar 9.
- Gorus FK, Weets I, Decochez K, van der Auwera BJ. [Preventative biology of type 1 diabetes: implications for clinical preventative studies]. Verh K Acad Geneeskd Belg. 2003;65(4):203-29; discussion 229-31. Dutch.
- 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.
- Vandemeulebroucke E, Keymeulen B, Decochez K, Weets I, De Block C, Fery F, Van de Velde U, Vermeulen I, De Pauw P, Mathieu C, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. Hyperglycaemic clamp test for diabetes risk assessment in IA-2-antibody-positive relatives of type 1 diabetic patients. Diabetologia. 2010 Jan;53(1):36-44. doi: 10.1007/s00125-009-1569-3. Epub 2009 Nov 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVDM IT 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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