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Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00339885
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date May 27, 2020
Actual Study Start Date June 1, 1996
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
T2D status, quantitative traits measurements [ Time Frame: ongoing ]
Association testing
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus
Official Title Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus
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....

Detailed Description

The Finland-United States investigation of NIDDM (FUSION) study is a long-term effort to

identify susceptibility genes for Type 2 diabetes (T2D) and associated quantitative traits. This

involves the phenotyping and DNA analysis of thousands of individuals living in Finland, utilizing a study design that was originally based on affected sib pairs. The majority of these samples have already been subjected to a genome scan using microsatellite markers and the original FUSION samples. Additionally, thousands of other northern European cases and controls have been subjected to genome-wide association (GWA) analysis and/or fine mapping as part of the FUSION study. More recently, the opportunity provided by the lowered sequencing costs have allowed targeted and/or whole genome sequencing of many of these individuals.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood DNA, Adipose, Muscle, Fibroblast, Serum
Sampling Method Non-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.
Condition
  • Genetic Variation
  • Diabetes
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2020)
32379
Original Enrollment
 (submitted: June 19, 2006)
13000
Actual Study Completion Date May 22, 2020
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • No eligibility criteria listed.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland,   Norway
Removed Location Countries Germany,   United States
 
Administrative Information
NCT Number NCT00339885
Other Study ID Numbers 999995030
OH95-HG-N030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Lori Bonnycastle, Ph.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 2020