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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source 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.

Overall Status Completed
Start Date July 2013
Completion Date October 2015
Primary Completion Date October 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling Over a one year period
Secondary Outcome
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
Enrollment 61
Condition
Intervention

Intervention Type: Other

Intervention Name: No treatment given

Description: The participants will not receive any treatment

Arm Group Label: All participants

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 14 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR,1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

United States

Verification Date

October 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: All participants

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov