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NCT Number: NCT01846312

An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with general good health as judged by the investigator
  • Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))

Exclusion criteria

  • Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
  • Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant

Treatment and study plan

No treatment given

Other

The participants will not receive any treatment.

Primary outcomes

  1. Fluctuation in islet autoantibodies titers

    Time frame: One-two years dependent on sampling frequency

Secondary outcomes

  1. Fluctuation in islet autoantibody isotypes

    Time frame: One-two years dependent on sampling frequency

  2. Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)

    Time frame: One-two years dependent on sampling frequency

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 3, 2013
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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