NCT00353600

Brief Summary

A clinical intervention will be performed in adult diabetic Pima Indians with proteinuria to determine if an angiotensin converting enzyme (ACE) inhibitor is effective in slowing the progression of renal disease in persons with overt diabetic nephropathy attributable to type 2 diabetes mellitus (NIDDM). The study will be conducted in the Gila River Indian Community and include proteinuric subjects selected from the Diabetic Renal Disease Study (DRDS; NIH Protocol Number 88-DK-79) in whom glomerular function has been measured at six-monthly intervals for the past 48 months. Twenty-five subjects (12 men, 13 women) aged 31-64 years are eligible for this study. These subjects all have urinary albumin-to-creatinine rations \>=300 mg/g (equivalent to 300 mg albumin/day), serum creatinine concentrations \< 3.0 mg/dl, and no evidence of nondiabetic renal diseases. Their GFR slopes average -0.49 ml/min/month (95% confidence interval, -0.91 to -0.07), and 11 of them (8 men, 3 women) are hypertensive (systolic blood pressure \>=140 mm Hg, diastolic blood pressure \>=90 mm Hg). Subjects will be treated with an ACE inhibitor, and measurements of glomerular filtration rate (GFR) and renal plasma flow (RPF) will be made at six monthly intervals until the subjects' progress to renal failure. GFR slope (ml.min/month) will be computed, and the slope prior to the initiation of an ACE inhibitor will be compared with that obtained during treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 1994

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2011

Completed
Last Updated

July 2, 2017

Status Verified

August 16, 2011

First QC Date

July 17, 2006

Last Update Submit

June 30, 2017

Conditions

Diabetic Nephropathy

Keywords

ProteinuriaRenal FailureAngiotension Converting Enzyme InhibitorGlomerular Filtration Rate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for participation in the study, subjects must meet the following criteria:
  • Previous completion of the DRDS;
  • Serum creatinine concentration less than 3.0 mg/dl;
  • Serum potassium concentration less than or equal to 5.7 mEq/L;
  • At least 2 of 3 screening urinary albumin-to-creatinine ratios greater than or equal to 300 mg/g;
  • Willingness, after receiving a thorough explanation of the study, to participate.
  • Severe hypertension will not affect eligibility for the study.

You may not qualify if:

  • In addition to the criteria outlined in the DRDS protocol, subjects with the following characteristics will be excluded:
  • Pregnancy. Women of childbearing age and not surgically sterilized must have a negative pregnancy test prior to entry and prior to each renal clearance study.
  • Hypersensitivity to ACE inhibitors.
  • Conditions that are likely to interfere with informed consent or compliance with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (3)

  • Anderson S, Rennke HG, Garcia DL, Brenner BM. Short and long term effects of antihypertensive therapy in the diabetic rat. Kidney Int. 1989 Oct;36(4):526-36. doi: 10.1038/ki.1989.227.

    PMID: 2681929BACKGROUND

  • Zatz R, Dunn BR, Meyer TW, Anderson S, Rennke HG, Brenner BM. Prevention of diabetic glomerulopathy by pharmacological amelioration of glomerular capillary hypertension. J Clin Invest. 1986 Jun;77(6):1925-30. doi: 10.1172/JCI112521.

    PMID: 3011862BACKGROUND

  • Zatz R, Meyer TW, Rennke HG, Brenner BM. Predominance of hemodynamic rather than metabolic factors in the pathogenesis of diabetic glomerulopathy. Proc Natl Acad Sci U S A. 1985 Sep;82(17):5963-7. doi: 10.1073/pnas.82.17.5963.

    PMID: 3862110BACKGROUND

MeSH Terms

Conditions

Diabetic NephropathiesProteinuriaRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

August 19, 1994

Study Completion

August 16, 2011

Last Updated

July 2, 2017

Record last verified: 2011-08-16

Locations

US(1)