Delaying the Progression of Diabetic Nephropathy in Pima Indians
Public ClinicalTrials.gov record NCT00353600. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00353600
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 1994
- Primary completion
- Not listed
- Completion
- Aug 15, 2011
- Last update posted
- Jul 1, 2017
1994 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NIDDK, Phoenix | Phoenix | Arizona | 85014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00353600, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00353600 live on ClinicalTrials.gov.