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

October 7, 2016 updated by: Novo Nordisk A/S

An Observational Study Evaluating 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All participants
Other: No treatment given
The participants will not receive any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
Time Frame: Over a one year period
Over a one year period

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation in CD4 +T-cell specificity profiling
Time Frame: Over a one year period
Over a one year period
Change in stimulated C-peptide
Time Frame: Baseline, one year
Baseline, one year
Fluctuation in islet autoantibodies titers
Time Frame: Over a one year period
Over a one year period
Variation in HbA1c (glycosylated haemoglobin)
Time Frame: Over a one year period
Over a one year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4099
  • U1111-1140-1650 (Other Identifier: WHO)

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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