NCT01115621

Brief Summary

The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

8.8 years

First QC Date

April 7, 2010

Last Update Submit

April 30, 2010

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Effect of dietary intervention on the development of islet autoantibodies

    Primary outcome is to compare the prevalence of iselt autoantibodies between children participating in the dietary intervention and the control group.

    3 years

Secondary Outcomes (1)

  • Effect of dietary intervention on the development of Type 1 diabetes.

    10 years

Study Arms (2)

Glutenfree diet

ACTIVE COMPARATOR

Glutenfree diet during the first year of life

Other: Glutenfree diet during the first year of life

Control - normal diet

NO INTERVENTION

Interventions

Glutenfree diet during the first year of lifeOTHER

Glutenfree diet during the first year of life

Glutenfree diet

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk

You may not qualify if:

  • If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetesforschung

München, 80804, Germany

Location

Related Publications (6)

  • Winkler C, Hummel S, Pfluger M, Ziegler AG, Geppert J, Demmelmair H, Koletzko B. The effect of maternal T1DM on the fatty acid composition of erythrocyte phosphatidylcholine and phosphatidylethanolamine in infants during early life. Eur J Nutr. 2008 Apr;47(3):145-52. doi: 10.1007/s00394-008-0708-9. Epub 2008 Apr 28.

    PMID: 18443841BACKGROUND

  • Pfluger M, Winkler C, Hummel S, Ziegler AG. Early infant diet in children at high risk for type 1 diabetes. Horm Metab Res. 2010 Feb;42(2):143-8. doi: 10.1055/s-0029-1241830. Epub 2009 Nov 9.

    PMID: 19902403BACKGROUND

  • Schmid S, Buuck D, Knopff A, Bonifacio E, Ziegler AG. BABYDIET, a feasibility study to prevent the appearance of islet autoantibodies in relatives of patients with Type 1 diabetes by delaying exposure to gluten. Diabetologia. 2004 Jun;47(6):1130-1. doi: 10.1007/s00125-004-1420-9. Epub 2004 May 28. No abstract available.

    PMID: 15168019RESULT

  • Laimighofer M, Lickert R, Fuerst R, Theis FJ, Winkler C, Bonifacio E, Ziegler AG, Krumsiek J. Common patterns of gene regulation associated with Cesarean section and the development of islet autoimmunity - indications of immune cell activation. Sci Rep. 2019 Apr 18;9(1):6250. doi: 10.1038/s41598-019-42750-5.

    PMID: 31000755DERIVED

  • Hummel S, Pfluger M, Hummel M, Bonifacio E, Ziegler AG. Primary dietary intervention study to reduce the risk of islet autoimmunity in children at increased risk for type 1 diabetes: the BABYDIET study. Diabetes Care. 2011 Jun;34(6):1301-5. doi: 10.2337/dc10-2456. Epub 2011 Apr 22.

    PMID: 21515839DERIVED

  • Adler K, Mueller DB, Achenbach P, Krause S, Heninger AK, Ziegler AG, Bonifacio E. Insulin autoantibodies with high affinity to the bovine milk protein alpha casein. Clin Exp Immunol. 2011 Apr;164(1):42-9. doi: 10.1111/j.1365-2249.2011.04324.x. Epub 2011 Mar 1.

    PMID: 21361910DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anette G Ziegler, MD

    Institut für Diabetesforschung, München, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

May 4, 2010

Study Start

February 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2016

Last Updated

May 4, 2010

Record last verified: 2010-04

Locations

DE(1)