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Renoprotection in Early Diabetic Nephropathy in Pima Indians

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ClinicalTrials.gov Identifier: NCT00340678
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : November 19, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetic Nephropathy
Interventions: Drug: Losartan
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled between 1996 and 2001, the last biopsy was performed in 2007, and morphometric evaluation was completed in 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 313 patients with type 2 diabetes who were screened, 79 were ineligible, 50 declined to participate, and 14 had other reasons that prevented participation despite meeting eligibility requirements.

Reporting Groups
  Description
Normoalbuminuria Losartan Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Normoalbuminuria Placebo Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
Microalbuminuria Losartan Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Microalbuminuria Placebo Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.

Participant Flow:   Overall Study
    Normoalbuminuria Losartan   Normoalbuminuria Placebo   Microalbuminuria Losartan   Microalbuminuria Placebo
STARTED   46   46   39   39 
COMPLETED   45   46   39   39 
NOT COMPLETED   1   0   0   0 
Lost to Follow-up                1                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of 170 subjects enrolled, one lost follow up. So all analysis was performed based on 169 subjects.

Reporting Groups
  Description
Normoalbuminuria Losartan Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Normoalbuminuria Placebo Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
Microalbuminuria Losartan Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Microalbuminuria Placebo Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
Total Total of all reporting groups

Baseline Measures
   Normoalbuminuria Losartan   Normoalbuminuria Placebo   Microalbuminuria Losartan   Microalbuminuria Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   46   39   39   170 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (10.6)   41.9  (11.7)   41.8  (8.9)   42.3  (10.9)   41.3  (10.6) 
Gender 
[Units: Participants]
         
Female   36   33   28   27   124 
Male   10   13   11   12   46 
Region of Enrollment 
[Units: Participants]
         
United States   46   46   39   39   170 
Diabetes duration 
[Units: Years]
Mean (Standard Deviation)
 8.8  (4.7)   10.4  (6.0)   10.3  (5.2)   14.1  (8.4)   10.8  (6.2) 
BMI [1] 
[Units: Kg/(m^2)]
Mean (Standard Deviation)
 37.4  (8.8)   36.6  (8.0)   34.6  (9.1)   33.8  (7.2)   35.7  (8.3) 
[1] Body Mass Index obtained by measuring the participant's height in meters and weight in kilograms.
Blood pressure, systolic 
[Units: mmHg]
Mean (Standard Deviation)
 115  (11)   118  (14)   118  (15)   123  (13)   118  (13) 
Blood pressure, diastolic 
[Units: mmHg]
Mean (Standard Deviation)
 75  (7)   75  (7)   77  (9)   77  (7)   76  (7) 
Blood pressure, mean 
[Units: mmHg]
Mean (Standard Deviation)
 88  (7)   89  (9)   90  (10)   92  (8)   90  (9) 
HbA1c [1] 
[Units: %]
Mean (Standard Deviation)
 9.2  (2.0)   8.1  (2.2)   9.5  (2.3)   10.3  (2.1)   9.2  (2.1) 
[1] Glycosylated hemoglobin is an integrated measure of glycemic control that reflects an average glycemic level over the past 3 months.
Glomerular filtration rate (GFR) [1] 
[Units: mL/min]
Mean (Standard Deviation)
 171  (38)   152  (40)   166  (43)   168  (43)   164  (41) 
[1] Glomerular filtration rate was measured by the urinary clearance of iothalamate.
Urinary albumin to creatinine ratio 
[Units: Mg/g]
Median (Inter-Quartile Range)
 15 
 (10 to 23) 
 14 
 (9 to 26) 
 66 
 (39 to 205) 
 80 
 (46 to 165) 
 47 
 (9 to 205) 


  Outcome Measures

1.  Primary:   Number of Participants With Decline in GFR   [ Time Frame: Up to 6 years ]

2.  Secondary:   Glomerular Volume   [ Time Frame: 6 years after first treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Renoprotection in Early Diabetic Nephropathy in Pima Indians
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
phone: (602) 200-5205
e-mail: rnelson@phx.niddk.nih.gov


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00340678     History of Changes
Other Study ID Numbers: 999995037
OH95-DK-N037 ( Other Identifier: NIH/NIDDK )
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: March 26, 2013
Results First Posted: November 19, 2013
Last Update Posted: July 24, 2014