NCT01184768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

August 11, 2010

Last Update Submit

July 19, 2011

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesHbA1cvitamin Ddiagnosis

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with new diagnosis of type 2 diabetes

    Up to 2 years after participation in the 6th Tromso study

Secondary Outcomes (3)

  • 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

  • Effect of vitamin D status on glucose tolerance

    Up to 2 years after participation in the 6th Tromso study

Study Arms (1)

participants in the 6th tromsø study

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • participated in the 6 Tromso study

You may not qualify if:

  • type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Tromsø, 9038, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • rolf jorde, md

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 19, 2010

Study Start

January 1, 2008

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

NO(1)