Trial Outcomes & Findings for Microalbuminuria in Children With and Without Diabetes (NCT NCT00320086)

Results Overview

Recruitment status

COMPLETED

Target enrollment

203 participants

Primary outcome timeframe

during hospitalization

Results posted on

2024-01-31

Patients were recruited from the University of New Mexico and via advertising and referral by other physicians.

Participant milestones
Measure	Arm 1 Control Arm: Evaluate Normal Urinary Protein Excretion in Healthy and Diabetic Children	Arm 2 Diabetes Arm: Children 6 to 18 years old with Type I or Type II Diabetes
Overall Study STARTED	91	112
Overall Study COMPLETED	91	112
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Microalbuminuria in Children With and Without Diabetes

Baseline characteristics by cohort
Measure	Arm 1 n=91 Participants Control Arm: children 6 to 18 years old without: * kidney disease * abnormal body temperature * history of documented urinary tract infection * metabolic disease * circulatory disease * liver disease * strenuous exercise in prior 24 hours * nocturnal enuresis	Arm 2 n=112 Participants Diabetes Arm: children 6 to 18 years old with Type I or Type II Diabetes without: * kidney disease * abnormal body temperature * history of documented urinary tract infection * metabolic disease other than diabetes mellitus * circulatory disease * liver disease * strenuous exercise in prior 24 hours * nocturnal enuresis	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	91 Participants n=5 Participants	112 Participants n=7 Participants	203 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	57 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	55 Participants n=7 Participants	101 Participants n=5 Participants

Timeframe: during hospitalization

Outcome measures
Measure	Arm 1 n=91 Participants Control Arm	Arm 2 n=112 Participants Diabetes Arm
Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day.	91 participants	112 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of New Mexico

Phone: (505)272-5551