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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339885
• Other study ID #: 999995030
• Secondary ID: OH95-HG-N030
• Status: Completed
• Start date: June 1, 1996
• Est. completion date: May 22, 2020

Study information

• Verified date: May 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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....

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32379
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 65 Years
• Eligibility: - No eligibility criteria listed.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Genetic Variation

Locations

Country	Name	City	State
Finland	Natl Inst for Health & Welfare (THL)	Helsinki
Finland	Research Ethics Committee of Hospital District of Northern Savo	Kuopio
Norway	University of Tromso	Tromso
Norway	Norwegian U of Science & Technology	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Countries where clinical trial is conducted

Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T2D status, quantitative traits measurements	Association testing	ongoing