Evaluation of Biomarker Expression in Diabetic and Health... | NCT01900834

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

NCT01900834

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 10, 2016Estimated

Enrollment

61Actual

Phase

Not provided

Conditions

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

Interventions

No treatment given

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1140-1650	Other Identifier	WHO

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2016

Last Update Posted Date

Oct 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants			Other: No treatment given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No treatment given	Other	The participants will not receive any treatment	All participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR,1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Princeton	New Jersey	08540	United States

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.