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Search / Trial NCT00342927

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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Jun 19, 2006

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

American Indians Complications Genetics Linkage Type 2 Diabetes Natural History Diabetic Kidney Disease

ClinConnect Summary

The Family Investigation of Nephropathy and Diabetes (F.I.N.D.) is a research study aimed at understanding the genetic factors that contribute to diabetic kidney disease. This study will take place at multiple sites across the United States and will include various ethnic groups. Researchers are looking for individuals with diabetes who also have kidney disease, specifically those whose condition is more severe than just early signs of kidney problems. If you or someone you know fits this description, family members like parents or siblings can also participate, helping the researchers gather important genetic information.

Eligible participants should be at least 18 years old and have a specific type of kidney damage related to diabetes. Those who join the study can expect to provide a blood sample for genetic testing and participate in discussions about their health. The ultimate goal of this trial is to identify genes that may make some people more likely to develop kidney disease, which could lead to better treatments and prevention strategies in the future. If you are interested in learning more about your eligibility or how to participate, feel free to reach out!

Gender

ALL

Eligibility 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.

About National Institute Of Diabetes And Digestive And Kidney Diseases (Niddk)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a prominent research institution within the National Institutes of Health (NIH) dedicated to advancing scientific knowledge and promoting health in the areas of diabetes, endocrine and metabolic disorders, obesity, digestive diseases, and kidney diseases. Through rigorous clinical trials and innovative research initiatives, NIDDK aims to improve prevention, diagnosis, and treatment strategies, ultimately enhancing patient outcomes and quality of life. The institute fosters collaboration among researchers, healthcare professionals, and community stakeholders to drive impactful discoveries and translate findings into effective healthcare solutions.

Locations

Phoenix, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Robert L Hanson, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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