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OpenTrials
Completed

NCT Number: NCT01900834

Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

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

  • T1D
  • Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
  • Age above or equal to 14 years and below or equal to 40 years
  • Body weight above 45 kg
  • T2D
  • Male or female subjects diagnosed within the last 15 years with good general health based on medical history
  • HbA1c between 6.5% and 10%
  • Body mass index (BMI) below 45 kg/m^2
  • Age above or equal to 18 and below 65 years
  • On insulin treatment
  • HS
  • Male or female subjects with good general heath based on medical history
  • Age above or equal to 18 years and below or equal to 40 years

Exclusion criteria

  • Any chronic disorder (besides T1D or T2D) 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. Variation in CD8 (cluster of differentiation) +T-cell specificity profiling

    Time frame: Over a one year period

Secondary outcomes

  1. Variation in CD4 +T-cell specificity profiling

    Time frame: Over a one year period

  2. Change in stimulated C-peptide

    Time frame: Baseline, one year

  3. Fluctuation in islet autoantibodies titers

    Time frame: Over a one year period

  4. Variation in HbA1c (glycosylated haemoglobin)

    Time frame: Over a one year period

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
Oct 10, 2016

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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