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Family Investigation of Nephropathy and Diabetes (F.I.N.D.)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342927
First received: June 19, 2006
Last updated: September 12, 2014
Last verified: August 2014
  Purpose

The Family Investigation of Nephropathy and Diabetes (FIND) is a multicenter study designed to identify genetic determinants of diabetic kidney disease. FIND will be conducted in eleven centers and in many ethnic groups throughout the United States. Two different strategies will be used to localize genes predisposing to kidney disease: a family-based genetic linkage study and a case-control study that utilizes admixture linkage disequilibrium. The center based at the Phoenix office of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK-Phoenix) will conduct family-based linkage studies among American Indian populations in the southwestern United States.

Participants (index cases) with diabetes and kidney disease will initially be recruited, and their parents and siblings will also be invited to participate. Genetic material from these participants will be used to genotype markers throughout the genome. Linkage analysis will be conducted to identify particular chromosomal regions containing genes that influence susceptibility to diabetic kidney disease. Linkage analyses will also be used to identify genes influencing traits related to diabetic kidney disease, such as serum creatinine, urinary protein excretion, plasma glucose levels, blood pressure and blood lipid levels. Regions that show evidence for linkage will then be examined in more detail, with both genetic linkage and association studies, to attempt to identify the specific genes that influence diabetic kidney disease, or related traits.

The identification of genes that influence susceptibility to diabetic kidney disease will lead to a better understanding of how kidney disease develops. In the long run, this may lead to improved treatment and prevention of diabetic kidney disease.


Condition
Diabetic Nephropathy
Diabetes Mellitus
Diabetic Kidney Disease
Albuminuria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Family Investigation of Nephropathy and Diabetes (F.I.N.D.)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: March 2001
Detailed Description:

The Family Investigation of Nephropathy and Diabetes (FIND) is a multicenter study designed to identify genetic determinants of diabetic kidney disease. FIND will be conducted in eleven centers and in many ethnic groups throughout the United States. Two different strategies will be used to localize genes predisposing to kidney disease: a familybased genetic linkage/association study and a case-control study that utilizes admixture linkage disequilibrium. The center based at the Phoenix office of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK-Phoenix) will conduct family-based linkage/association studies among American Indian populations in the southwestern United States, and in the indigenous Micronesian populations of the Territory of Guam and the Commonwealth of the Northern Mariana Islands (CNMI).

Participants (index cases) with diabetes and kidney disease will initially be recruited, and their parents and siblings will also be invited to participate. Genetic material from these participants will be used to genotype markers throughout the genome. Linkage analyses will be conducted to identify particular chromosomal regions containing genes that influence susceptibility to diabetic kidney disease. Linkage analyses will also be used to identify genes influencing traits related to diabetic kidney disease, such as serum creatinine, urinary protein excretion, plasma glucose levels, blood pressure and blood lipid levels. Regions that show evidence for linkage will then be examined in more detail, with both genetic linkage and association studies, to attempt to identify the specific genes that influence diabetic kidney disease, or related traits.

The identification of genes that influence susceptibility to diabetic kidney disease will lead to a better understanding of how kidney disease develops. In the long run, this may lead to improved treatment and prevention of diabetic kidney disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Index Cases:

Individuals with diabetes and diabetic nephropathy who are at least 18 years of age.

Potential index cases must have at least one sibling, or both parents available as potential study participants.

Potential index cases must also have diabetic nephropathy. An index case must have nephropathy that is more severe than microalbuminuria. An index case must meet one of the following criteria:

  1. Biopsy proven diabetic nephropathy (by medical record review):

    1. Nodular and/or diffuse increases in the mesangial matrix accumulation; and
    2. Thickened glomerular basement membranes and/or arteriolar hyalinization; and
    3. Absence of mesangial immunoglobulin or paraprotein deposits by immunoflorecscence microscopy, absence of amyloid deposits by Congo Red staining or electron microscopy, absence of electron dense deposits within the glomerular basement membrane or glomerular capillary subendothelial space; and
    4. Overt proteinuria, defined as ACR greater than or equal to 300 mg/g, urinary protein creatinine ratio greater than or equal to 0.5 g/g, urinary albumin excretion greater than or equal to 300 mg/24 hr, or urinary protein excretion greater than or equal to 0.5 g/24 hr.
  2. ESRD (including transplant) from presumed diabetic nephropathy:

    Diabetes present for at least 5 years prior to the initiation of replacement therapy and retinopathy at any time;

    or Diabetes present for at least 5 years prior to the initiation of replacement therapy and either greater than or equal to 3 gm protein/24 hours, or a urine protein (mg)/creatinine (mg) greater than or equal to 3.0 or urinary ACR greater than or equal to 3000 mg/g or urinary albumin excretion greater than or equal to 3000 mg/24 hours (historical data acceptable);

    or retinopathy and either greater than or equal to 3 gm protein/24 hours, or a urine protein (mg)/creatinine (mg) greater than 3.0 or urinary ACR greater than or equal to 3000 mg/g or urinary albumin excretion greater than 3000 mg/24 hours (historical data acceptable).

  3. Patient with presumed diabetic nephropathy but not ESRD:

Patient has diabetic retinopathy and either greater than or equal to 1 gram proteinuria/24 hours or a urine protein (mg)/creatinine (mg) greater than or equal to 1.0 or urinary ACR greater than or equal to 1000 mg/g or urinary albumin excretion greater than or equal to 1000 mg/24 hours (historical data acceptable);

or first detection of either greater than or equal to 3 gram protein/24 hours or a urine protein (mg)/creatinine (mg) greater than or equal to 3.0 gram or urinary ACR greater than or equal to 3000 mg/g or urinary albumin excretion greater than or equal to 3000 mg/24 hours at DM duration greater than or equal to 10 years (historical data acceptable).

Recruitment of Family Members:

Any available parent or sibling who is at least 18 years of age will be recruited as a potential participant and will use the same criteria as above.

DNA for individuals in informative families will be submitted to the genotyping laboratory. An informative family is defined as one for which DNA specimens are available for the following individuals:

  1. The index case and both parents, or
  2. The index case and at least one other affected sibling who has diabetes and renal disease, or
  3. The index case and at least one unaffected sibling, defined as an individual who has had diabetes for at least 10 years and who has no renal disease (based on evidence obtained from the medical record and from the FIND examination.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342927

Contacts
Contact: William C Knowler, M.D. (602) 200-5206 wknowler@phx.niddk.nih.gov

Locations
United States, Arizona
NIDDK, Phoenix Recruiting
Phoenix, Arizona, United States, 85014
Contact: William Knowler, M.D.    602-200-5206    wknowler@phx.niddk.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: William C Knowler, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00342927     History of Changes
Other Study ID Numbers: 999901117, 01-DK-N117
Study First Received: June 19, 2006
Last Updated: September 12, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
American Indians
Complications
Genetics
Linkage
Type 2 Diabetes
Diabetic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Diabetes Mellitus
Diabetic Nephropathies
Albuminuria
Urologic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Complications
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014