The Family Investigation of Nephropathy and Diabetes Study

NCT00301249 | Completed

• 2 other identifiers: FIND U01DK057292U01DK057292
• Study Type: observational
• Target: 9,031
• Locations: 1 country
• Sites: 5

Brief Summary

The Family Investigation of Nephropathy and Diabetes (FIND)Study is a multi-center consortium. The charge of the consortium is to acquire sets of families with well-characterized diabetic nephropathy, establish a secure master FIND database, and perform a genome scan to identify chromosomal regions linked with diabetic nephropathy.

Conditions

Diabetes; Diabetic Nephropathy

Keywords

Diabetes; Nephropathy; Diabetic Nephropathy; Genome Scan; Genetic Research

Study Arms (3)

Family Investigation of Nephropathy and Diabetes (FIND)

Individuals with diabetic nephropathy, their parents, and selected siblings

African American MALD

Case-control study of African American patients with nephropathy (cases) and their spouses (controls) unaffected by diabetes and nephropathy; offspring were genotyped when available to provide haplotype data.

Mexican American MALD

Case-control study of unrelated individuals of Mexican American heritage in which both cases and controls had diabetes, but only the case had nephropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Family protocol, proband must meet diagnostic criteria for diabetes and have nephropathy that meets one of the following:
• diabetic nephropathy diagnosed from a kidney biopsy and a history of overt proteinuria.
• ESRD considered due to diabetic nephropathy because
• diabetes is present for ≥ 5 years prior to the initiation of renal replacement therapy and diabetic retinopathy has been diagnosed at any time; or
• diabetes is present ≥ 5 years prior to the initiation of replacement therapy and either a 24 hour urine collection contains ≥ 3 gm protein/24 hours or a random urine protein (mg/dl)/ creatinine (mg/dl) ratio is ≥ 3.0; or
• diabetic retinopathy is present and either a previous 24 hour urine collection contains ≥ 3 gm protein/24 hours or a random urine protein (mg/dl)/ creatinine (mg/dl) ratio is ≥ 3.0.
• nephropathy without ESRD that is considered to be diabetic nephropathy because (a) diabetic retinopathy and a 24 hr urine collection with either ≥ 1 gram proteinuria/24 hours or a urine protein (mg/dl)/ creatinine (mg/dl) ratio ≥ 1.0; or (b) at a time when diabetes duration is ≥ 10 years, either a urine collection of ≥ 3 grams protein/24 hours or a urine protein (mg/dl) /creatinine (mg/dl) ratio ≥ 3.0.
• African-American patients with chronic renal failure are as MALD cases by meeting criteria for diabetic nephropathy, as described for Family probands, or having nephropathy (serum creatinine ≥ 2.0 mg/dl) not due to diabetes or known monogenic renal disease. Mexican-Americans recruited as MALD cases must meet criteria for diabetic nephropathy as defined for the Family probands. Phenotype criteria for probands entered into the Family or MALD protocols must be confirmed by medical record review.
• Eligibility of family members and MALD control subjects is based on laboratory tests obtained at the time of screening. Entry of a proband with diabetic nephropathy into the Family protocol also requires participation of either two living parents or at least one full sibling with diabetes. To be enrolled as having nephropathy, the diabetic sib must meet one of the following criteria:
• renal biopsy consistent with a diagnosis of diabetic nephropathy;
• urinary albumin excretion ≥ 30 mg/24hr or a urine albumin (mg/dl)/creatinine (mg/dl) ratio ≥ 0.03;
• a serum creatinine concentration ≥ 1.6 mg/dl for men or ≥ 1.4 mg/dl for women; or
• ESRD. Unaffected sibs are recruited if they have had diabetes for ≥ 10 years, have normal serum creatinine and albumin excretion (\< 30 mg albumin/24 hours, or a urine albumin (mg/dl)/creatinine (mg/dl) ratio \< 0.03) and no historical evidence of kidney disease.
• The criteria for MALD control subjects differ by ethnic group. For the African-American MALD protocol, two different control samples are recruited. First, an adult offspring with or without renal disease and the other parent of the offspring, who cannot have evidence of renal disease, are collected as controls for African-American probands with either diabetic or non-diabetic nephropathy. Together with the probands, this forms a sample of triads (offspring and other parent) or dyads (spouse only). A second group of African-American control subjects consists of unrelated individuals with diabetes duration ≥ 10 years and without nephropathy (as defined above for diabetic sibs). For Mexican Americans, a single unrelated control population is recruited with diabetes duration ≥ 10 years but without nephropathy (as defined above for diabetic sibs).

You may not qualify if:

• A. Did not sign the informed consent: refusal to participate. B. Diagnosis not confirmed. C. Appropriate siblings not available. D. Judged not likely or unable to follow study protocol. E. Ethnicity of parents or grandparent not suitable. F. Spouse not available.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Case Western Reserve University: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21234, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (5)

• Knowler WC, Coresh J, Elston RC, Freedman BI, Iyengar SK, Kimmel PL, Olson JM, Plaetke R, Sedor JR, Seldin MF; Family Investigation of Nephropathy and Diabetes Research Group. The Family Investigation of Nephropathy and Diabetes (FIND): design and methods. J Diabetes Complications. 2005 Jan-Feb;19(1):1-9. doi: 10.1016/j.jdiacomp.2003.12.007.

  PMID: 15642484 BACKGROUND

• Bostrom MA, Kao WH, Li M, Abboud HE, Adler SG, Iyengar SK, Kimmel PL, Hanson RL, Nicholas SB, Rasooly RS, Sedor JR, Coresh J, Kohn OF, Leehey DJ, Thornley-Brown D, Bottinger EP, Lipkowitz MS, Meoni LA, Klag MJ, Lu L, Hicks PJ, Langefeld CD, Parekh RS, Bowden DW, Freedman BI; Family Investigation of Nephropathy and Diabetes (FIND) Research Group. Genetic association and gene-gene interaction analyses in African American dialysis patients with nondiabetic nephropathy. Am J Kidney Dis. 2012 Feb;59(2):210-21. doi: 10.1053/j.ajkd.2011.09.020. Epub 2011 Nov 25.

  PMID: 22119407 RESULT

• Iyengar SK, Abboud HE, Goddard KA, Saad MF, Adler SG, Arar NH, Bowden DW, Duggirala R, Elston RC, Hanson RL, Ipp E, Kao WH, Kimmel PL, Klag MJ, Knowler WC, Meoni LA, Nelson RG, Nicholas SB, Pahl MV, Parekh RS, Quade SR, Rich SS, Rotter JI, Scavini M, Schelling JR, Sedor JR, Sehgal AR, Shah VO, Smith MW, Taylor KD, Winkler CA, Zager PG, Freedman BI; Family Investigation of Nephropathy and Diabetes Research Group. Genome-wide scans for diabetic nephropathy and albuminuria in multiethnic populations: the family investigation of nephropathy and diabetes (FIND). Diabetes. 2007 Jun;56(6):1577-85. doi: 10.2337/db06-1154. Epub 2007 Mar 15.

  PMID: 17363742 RESULT

• Igo RP Jr, Iyengar SK, Nicholas SB, Goddard KA, Langefeld CD, Hanson RL, Duggirala R, Divers J, Abboud H, Adler SG, Arar NH, Horvath A, Elston RC, Bowden DW, Guo X, Ipp E, Kao WH, Kimmel PL, Knowler WC, Meoni LA, Molineros J, Nelson RG, Pahl MV, Parekh RS, Rasooly RS, Schelling JR, Shah VO, Smith MW, Winkler CA, Zager PG, Sedor JR, Freedman BI; Family Investigation of Nephropathy and Diabetes Research Group. Genomewide linkage scan for diabetic renal failure and albuminuria: the FIND study. Am J Nephrol. 2011;33(5):381-9. doi: 10.1159/000326763. Epub 2011 Mar 31.

  PMID: 21454968 RESULT

• Thameem F, Igo RP Jr, Freedman BI, Langefeld C, Hanson RL, Schelling JR, Elston RC, Duggirala R, Nicholas SB, Goddard KA, Divers J, Guo X, Ipp E, Kimmel PL, Meoni LA, Shah VO, Smith MW, Winkler CA, Zager PG, Knowler WC, Nelson RG, Pahl MV, Parekh RS, Kao WH, Rasooly RS, Adler SG, Abboud HE, Iyengar SK, Sedor JR; Family Investigation of Nephropathy and Diabetes Research Group. A genome-wide search for linkage of estimated glomerular filtration rate (eGFR) in the Family Investigation of Nephropathy and Diabetes (FIND). PLoS One. 2013 Dec 17;8(12):e81888. doi: 10.1371/journal.pone.0081888. eCollection 2013.

  PMID: 24358131 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Nephropathies; Kidney Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Sudha Iyengar, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Barry I Freedman, MD

  Wake Forest University

  STUDY CHAIR

• Sharon Adler, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Hanna Abboud, MD

  University of Texas Health Sciences Center at San Antonio

  PRINCIPAL INVESTIGATOR

• John R Sedor, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Rulan Parekh, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Philip Zager, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• William Knowler, MD, PhD

  NIDDK-Phoenix

  PRINCIPAL INVESTIGATOR

• Susanne Nicholas, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Rebekah Rasooly, PhD

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

  STUDY DIRECTOR

• Paul Kimmel, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 10, 2006
• Study Start: October 1, 1999
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)