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

NCT01900834 | Completed

• 2 other identifiers: INS-4099U1111-1140-1650
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Variation in CD8 (cluster of differentiation) +T-cell specificity profiling

  Over a one year period

Secondary Outcomes (4)

• 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

Study Arms (1)

All participants

Other: No treatment given

Interventions

No treatment given OTHER

The participants will not receive any treatment

All participants

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

Biospecimen

Retention: SAMPLES WITH DNA

Monthly venous blood samples within the first half year and thereafter bi-monthly the rest of the year. A subgroup of the subjects will also be invited for a visit within a week after the former visit to assess the variation of the biomarkers within a week. The blood samples will be assayed for peripheral blood mononuclear cells (PBMC) specificity, phenotype and function as well as for islet autoantibodies (presence and precise titers), for autoantibody isotypes and diabetes risk parameters. Finally C-peptide levels and residual beta cell function will be measured three times during the study after a mix meal tolerance test (MMTT) in subjects with T1D.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR,1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

US (1)