TCTR20200724002CompletedPhase 1
The Effect of Oral Carnosine Supplementation on Urinary TGF-beta in Diabetic Nephropathy: A Randomized Controlled Trial
/A0 sites40 target enrollmentStarted: July 24, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to N/A (No limit) (—)
- Sex
- All
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.
Investigators
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