ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00339885
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

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.


Condition or disease
Genetic Variation Diabetes

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
Estimated Enrollment : 60000 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Mapping Genes for Type 2 (Non-Insulin Dependent) Diabetes Mellitus
Actual Study Start Date : March 24, 1995

Resource links provided by the National Library of Medicine


Group/Cohort
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
AADM
Family and Population based individuals
FINRISK 2002
Population based individuals; Test DNA
Health-2000
Population based individuals
Action-LADA
Population based individuals
D2D 2004
Population based individuals
FINRISK 1987
Population based individuals
Savitaipale
Population based individuals
DIAGEN (Dresden Biobank)
Population based individuals
METSIM
Population based individuals
HUNT 2
Population based individuals
FUSION Finnish Groups
Family and Population based (including METSIM and DR's EXTRA): Tissue samples
UEF - Laakso
Monogenic disease individuals and family members



Primary Outcome Measures :
  1. T2D status, quantitative traits measurements [ Time Frame: ongoing ]
    Association testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria
  • No eligibility criteria listed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339885


Contacts
Contact: Ann C. M. Smith (301) 435-5475 acmsmith@nhgri.nih.gov
Contact: Lori Bonnycastle, Ph.D. (301) 594-9206 lbonnyca@mail.nih.gov

Locations
Finland
Natl Inst for Health & Welfare (THL) Recruiting
Helsinki, Finland
Contact: Heikki Koistinen    358400416    heikki.koistinen@helsinki.fi   
Research Ethics Committee of Hospital District of Northern Savo Recruiting
Kuopio, Finland
Contact: Markku Laasko    35840672      
Norway
University of Tromso Recruiting
Tromso, Norway
Contact: Inger Njolstad    Not Listed    Inger.Njolstad@ism.uit.no   
Norwegian U of Science & Technology Recruiting
Trondheim, Norway
Contact: Kristian Hveem    Not Listed    kristian.hveem@ntnu.no   
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Lori Bonnycastle, Ph.D. National Human Genome Research Institute (NHGRI)

Publications:
Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT00339885     History of Changes
Other Study ID Numbers: 999995030
OH95-HG-N030
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: July 27, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Monogenic Diabetes
Type 2 Diabetes Mellitus
QTL

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases