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

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes; Healthy
• Interventions: Other: No treatment given

• Registration Number: NCT01900834
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-28
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling	Over a one year period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Princeton, New Jersey, United States