NCT00339885

Brief Summary

The aim of the project is to positionally clone susceptibility genes for NIDDM. Patients will be ascertained in Finland from previous health surveys and hospital discharge records. Approximately 400 affected sib pairs will be collected. Families will be chosen who have, at most, one parent with NIDDM no history of IDDM. A clinical examination will be undertaken on family members and blood drawn for DNA isolation. Covariates such as body weight, blood pressure, lipid levels and urinary albumin will also be measured. The unaffected spouse and children of a subset of probands will be invited to undergo a frequently-sampled intravenous glucose tolerance test (FSIGT) to measure parameters of pancreatic function and peripheral insulin resistance (IR). A number of unrelated elderly non-diabetic subjects will also be identified to conduct a population-based association analysis. The FSIGT analysis will be performed in Los Angeles. The DNA will be shipped to Bethesda where a total genomic scan will be performed using semi-automated fluorescence-based genotyping technology. Data from Bethesda, Los Angeles and Finland will be sent to Ann Arbor where parametric and non-parametric methods will be used to analyse both discrete traits such as NIDDM and intermediate traits like IR....

Trial Health

90
On Track

Trial Health Score

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

Enrollment
32,379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1996

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

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

June 1, 1996

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

24 years

First QC Date

June 19, 2006

Last Update Submit

May 22, 2020

Conditions

Keywords

Monogenic DiabetesType 2 Diabetes MellitusQTL

Outcome Measures

Primary Outcomes (1)

  • T2D status, quantitative traits measurements

    Association testing

    ongoing

Study Arms (16)

AADM

Family and Population based individuals

Action-LADA

Population based individuals

D2D 2004

Population based individuals

DIAGEN (Dresden Biobank)

Population based individuals

FINRISK 1987

Population based individuals

FINRISK 2002

Population based individuals; Test DNA

Fusion 1

Affected-sib pair (ASP) families and elderly controls

Fusion 2

275 Replication ASP Families; Trios

Fusion 3

Siblings of FUSION1 families; Spouses, Offspring of 291 FUSION 1 families; Spouses, Offspring of Elderly Controls; Other F1 relatives

Fusion 4/5

Spouses, Offspring of FUSION 1 and 2 Families

FUSION Finnish Groups

Family and Population based (including METSIM and DR's EXTRA): Tissue samples

Health-2000

Population based individuals

HUNT 2

Population based individuals

METSIM

Population based individuals

Savitaipale

Population based individuals

UEF - Laakso

Monogenic disease individuals and family members

Eligibility Criteria

Age1 Month - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A large majority of the sample population resides in various parts of Finland and are of Finnish descent. The Finnish population provides an ideal basis for studies of complex genetic diseases such as T2D due to its relative genetic and environmental homogeneity, excellent data sources, and a population strongly supportive of biomedical research. Individuals with or without diabetes (type2 or monogenic forms of diabetes) have been collected.

* No eligibility criteria listed.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Natl Inst for Health & Welfare (THL)

Helsinki, Finland

Location

Research Ethics Committee of Hospital District of Northern Savo

Kuopio, Finland

Location

University of Tromso

Tromsø, Norway

Location

Norwegian U of Science & Technology

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood DNA, Adipose, Muscle, Fibroblast, Serum

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lori Bonnycastle, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

June 1, 1996

Primary Completion

May 22, 2020

Study Completion

May 22, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations