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The Effect of Oral Carnosine Supplementation on Urinary TGF-beta in Diabetic Nephropathy: A Randomized Controlled Trial

Phase 1
Completed
Conditions
Diabetic nephropathy with aged over 18 yrs
Carnosine, diabetic nephropathy, transforming growth factor beta
Registration Number
TCTR20200724002
Lead Sponsor
/A
Brief Summary

rinary TGF-beta significantly decreased with carnosine supplement (-17.8% of the baseline values), whereas it tended to increase with placebo (+16.9% of the baseline values) (between-group difference. Whereas, blood urea nitrogen, serum creatinine, glomerular filtration rate and other biochemical parameters did not change during the study period including urinary albuminuria. The both groups were well tolerated with no serious side-effects.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria

The inclusion criteria were T2DM, age of 18 years old or older, urine albumin-creatinine ratio (UACR) of 30-299 mg/g creatinine at least 2 in 3 within 3 to 6 months, stable dose of ACEI or ARB for blood pressure control at least 3 months before enrolling, and stable hemoglobinA1C (HbA1C) within 3 months prior to the study.

Exclusion Criteria

The exclusion criteria were active infections, chronic kidney disease from non-diabetic cause, advanced malignancy, history of hypersensitivity to protein nutrients, problems with nutrients absorption of gastrointestinal tract and liver disease.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome was the decrease in the level of urinary levels of TGF-β at 12 weeks after start of the intervention solid-phase specific sandwich enzyme-linked immunosorbent assay (ELISA)
Secondary Outcome Measures
NameTimeMethod
secondary outcome was the decrease in the level of urine albumin/creatinine ratio at 12 weeks after start of the intervention immunonephelometric assay
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