HBA1c and Diagnosis of Type 2 Diabetes | NCT01184768

Studies
HBA1c and Diagnosis of Type 2 Diabetes

NCT01184768

Sponsor

University of Tromso

Status

Completed

Last Update Posted

Jul 20, 2011Estimated

Enrollment

3,509Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

Not provided

Countries

Norway

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

Status Module

Record Verification Date

Jul 2011

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

Jan 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Aug 11, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

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

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

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

Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,509Actual

Label	Type	Description	Intervention Names
participants in the 6th tromsø study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with new diagnosis of type 2 diabetes		Up to 2 years after participation in the 6th Tromso study

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects with new diagnosis of impaired glucose tolerance		Up to 2 years after participation in the 6th Tromso study
Number of subjects with new diagnosis of impaired fasting glucose		Up to 2 years after participation in the 6th Tromso study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participated in the 6 Tromso study

Exclusion Criteria:

type 2 diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

random sample of subjects living in Tromso and who participated in the 6 th Tromsø study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
rolf jorde, md	University of Tromso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø	Tromsø	9038	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D004194	Disease

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided