Diabetic Kidney Disease (DKD)
Conditions
Keywords
Diabetic kidney disease, Oligo-fucoidan, Fucoxanthin, eGFR, Albuminuria
Brief summary
The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of fucoidan/fucoxanthin/L-carnitine combinaed therapy in patients with diabetic kidney disease. Participants were randomly assigned in a 1:1 ratio to either the Treatment Group or the Control Group. The primary objective is to investigate whether fucoidan/fucoxanthin/L-carnitine/Zinc yeast combinaed therapy can significantly improve albuminuria or renal function after a treatment period of 12 weeks. Secondary outcomes include evaluating the safety profile and potential side effects of the intervention. It is hypothesized that the intervention will show a beneficial effect on albuminuria compared to the control group. in patients withdiabetic kidney disease.
Interventions
DIETARY_SUPPLEMENTOligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)
Combined marine-derived formulation administered orally in capsule form. Each day, participants took 4 capsules, providing a total daily dose of 740 mg of low-molecular-weight oligo-fucoidan, 1200 mg of fucoxanthin-containing extract, and 120 mg of L-carnitine. The intervention was used as an add-on therapy to standard diabetic kidney disease care for a total duration of 12 weeks.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a randomized, open-label, parallel-group trial with a 1:1 allocation ratio. Eligible participants were assigned to either the FFL group or the control group. Both groups maintained their optimized standard-of-care treatments for diabetic kidney disease (including SGLT2 inhibitors and ACEIs/ARBs) unchanged throughout the entire 12-week study period.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented glycated hemoglobin (HbA1c) \> 6.5% with current use of anti-diabetic medication. * A urine albumin-to-creatinine ratio (UACR) greater than 30 mcg/mg.
Exclusion criteria
* Age younger than 20 years. * Inability to understand or provide written informed consent. * Absence of regular treatment for diabetes mellitus. * Medication non-compliance, defined as completing less than 50% of the prescribed formula (FFL) treatment. * Newly diagnosed glomerulonephritis during the study period. * Loss to follow-up, defined as failure to complete all laboratory tests required for outcome assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) | Baseline and Week 12 | The UACR was assessed via random spot urine collection. The primary outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekUACR-BaselineUACR)/BaselineUACR\\) \* 100%. A negative percentage indicates a reduction in albuminuria (improvement). |
| Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline and Week 12 | Serum creatinine was measured and eGFR was calculated using the 2021 CKD-EPI creatinine equation. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekeGFR-BaselineeGFR)/BaselineeGFR\\) \* 100%. This parameter was evaluated to monitor for any acute hemodynamically-induced decline (eGFR dip) upon treatment initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline and Week 12 | Blood samples were collected to analyze HbA1c levels for evaluating glycemic control. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekHbA1c-BaselineHbA1c)/BaselineHbA1c\\) \* 100%. |
| Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline and Week 12 | Fasting lipid profiles were analyzed to evaluate lipid metabolism. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekLDL-C-BaselineLDL-C)/BaselineLDL-C\\) \* 100%. |
Countries
Taiwan
Outcome results
None listed