Trial · NCT00179777
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
NCT00179777, Not applicable, Completed, University of Helsinki; results first posted 2021-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk. Trials, record NCT00179777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00179777
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
- NCT number
- NCT00179777
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,156 participants, actual
- Lead sponsor
- University of Helsinki
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Hydrolysed infant formula, Nonhydrolysed infant formula
- First posted
- 2005-09-16
- Last updated
- 2021-07-30
- Results first posted
- 2021-07-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Type 1 Diabetes Mellitus | 12 and 18 months and annually from 2 years up to 14 years | Number of participants with Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age and in the final year of the study. |
| Secondary | Number of Participants With Diabetes Associated Autoantibodies | 3, 6, 9, 12, 18 months and annually from 2 years up to 14 years | Diabetes associated autoantibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12, and 18 months of age, and annually from age 2 to 10-14 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Type 1 Diabetes Mellitus | 12 and 18 months and annually from 2 years up to 14 years | Analysis population consisted of participants with increased genetic risk (defined HLA genotypes) for type 1 diabetes | participants | NUMBER |
| SECONDARY | Number of Participants With Diabetes Associated Autoantibodies | 3, 6, 9, 12, 18 months and annually from 2 years up to 14 years | Analysis population consisted of participants with increased genetic risk (defined HLA genotypes) for type 1 diabetes | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Type 1 Diabetes Mellitus | Nonhydrolysed Infant Formula | 82 | participants | ||
| Number of Participants With Type 1 Diabetes Mellitus | Hydrolysed Infant Formula | 91 | participants | ||
| Number of Participants With Diabetes Associated Autoantibodies | Nonhydrolysed Infant Formula | ICA+ | 373 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Hydrolysed Infant Formula | ICA+ | 394 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Nonhydrolysed Infant Formula | IAA+ | 162 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Hydrolysed Infant Formula | IAA+ | 183 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Nonhydrolysed Infant Formula | GADA+ | 186 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Hydrolysed Infant Formula | GADA+ | 207 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Nonhydrolysed Infant Formula | IA-2A+ | 102 | Participants | |
| Number of Participants With Diabetes Associated Autoantibodies | Hydrolysed Infant Formula | IA-2A+ | 115 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrolysed Infant Formula | 2,613 | |
| Overall Study | STARTED | Nonhydrolysed Infant Formula | 2,543 | |
| Overall Study | COMPLETED | Hydrolysed Infant Formula | 1,081 | |
| Overall Study | COMPLETED | Nonhydrolysed Infant Formula | 1,078 | |
| Overall Study | NOT COMPLETED | Hydrolysed Infant Formula | 1,532 | |
| Overall Study | NOT COMPLETED | Nonhydrolysed Infant Formula | 1,465 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Nonhydrolysed Infant Formula | 772 | 1,078 | 6,206 |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Hydrolysed Infant Formula | 754 | 1,081 | 5,952 |
| other | Gastroenteritis | Gastrointestinal disorders | Nonhydrolysed Infant Formula | 515 | 1,078 | 1,519 |
| other | Gastroenteritis | Gastrointestinal disorders | Hydrolysed Infant Formula | 494 | 1,081 | 1,598 |
| other | Urinary Tract Infection | Renal and urinary disorders | Nonhydrolysed Infant Formula | 91 | 1,078 | 123 |
| other | Urinary Tract Infection | Renal and urinary disorders | Hydrolysed Infant Formula | 80 | 1,081 | 130 |
| other | Middle Ear Infection | Ear and labyrinth disorders | Nonhydrolysed Infant Formula | 534 | 1,078 | 1,951 |
| other | Middle Ear Infection | Ear and labyrinth disorders | Hydrolysed Infant Formula | 525 | 1,081 | 1,796 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Nonhydrolysed Infant Formula | 93 | 1,078 | 119 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Hydrolysed Infant Formula | 91 | 1,081 | 110 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nonhydrolysed Infant Formula | 5 | 1,078 |
| Total, all-cause mortality | Hydrolysed Infant Formula | 5 | 1,081 |
| Total, other adverse events | Nonhydrolysed Infant Formula | 1,010 | 1,078 |
| Total, other adverse events | Hydrolysed Infant Formula | 1,012 | 1,081 |
| Total, serious adverse events | Nonhydrolysed Infant Formula | 379 | 1,078 |
| Total, serious adverse events | Hydrolysed Infant Formula | 377 | 1,081 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HD040364 | Trial to Reduce IDDM in the Genetically at Risk -study | KNIP, MIKAEL | UNIVERSITY OF HELSINKI | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U01HD042444 | Trial to Reduce IDDM in the Genetically at Risk: A Nutritional primary prevention | BECKER, DOROTHY J | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nonhydrolysed Infant Formula vs Hydrolysed Infant Formula: Number of Participants With Type 1 Diabetes Mellitus | Trial comparisons |
| Nonhydrolysed Infant Formula vs Hydrolysed Infant Formula: deaths from any cause | Trial comparisons |
| Nonhydrolysed Infant Formula vs Hydrolysed Infant Formula: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00179777
GET https://conductscience.org/api/trials/v1/NCT00179777/events?page=2