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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01900834

Enrollment

Registered

2013-07-17

Start date

2013-07-31

Completion date

2015-10-31

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Healthy

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.

Interventions

OTHERNo treatment given

The participants will not receive any treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026