Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 Diabetes
Open Label Evaluator Blind,The Effect of Proliverenol Supplementation on the Visceral Adiposity Index, HOMA-IR, C-Peptide, and Controlled Attenuation Parameter (CAP) in Patients With Type 2 Diabetes at Dr. Mohammad Hoesin General Hospital in Palembang.
This study aims to determine whether Proliverenol supplementation can improve liver fat levels and blood sugar control in patients with type 2 diabetes. Participants will be divided into two groups: one group will receive Proliverenol with standar therapy of DM, and the other only receive standar therapy of DM. The study will last for 12 weeks, and participants will undergo blood tests and liver examinations."
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Type 2 diabetes mellitus, or diabetes, is a chronic and progressive disease characterized by elevated blood sugar levels above normal. Several key mechanisms contribute to this condition, including increased oxidative stress, chronic inflammation, and the death of pancreatic β cells. This condition is exacerbated by excessive weight gain.
Proliverenol, derived from the mahkota dewa fruit (P. macrocarpa), contain an antioxidant that reduces inflammation and prevents pancreatic β-cell death. As a result, it can reduce insulin resistance in muscle and liver tissues and improve insulin secretion.
Expected results: A reduction in insulin resistance, an increase in insulin secretion, and improvements in other metabolic parameters after 3 months of proliverenol administration.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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South Sumatera
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Palembang, South Sumatera, Indonesia, 30128
- Rekruttering
- University of Sriwijaya Palembang
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Ta kontakt med:
- Dian Wijayanti, dr. Dian Wijayanti, SpPD
- Telefonnummer: +62811-7870-993
- E-post: dyan.wijayanti@gmail.com
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Hovedetterforsker:
- Zainal Fahmi, dr. Zainal Fahmi, SpPD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All patients diagnosed with Type 2 diabetes
- VAI values: women > 0.705, men > 1.48, or CAP values ≥ 236
- Ages 30-65 years
- Receiving standard Type 2 diabetes treatment for at least 3 months with HbA1c levels between 7% and 9.5%.
- Willing to participate in the study by signing an informed consent form.
Exclusion Criteria:
- Taking long-term steroid medication, either oral or systemic.
- Pregnant or breastfeeding women
- History of or currently suffering from an autoimmune disease
- History of or previous infection with hepatitis B or C
- ALT/AST levels > 2x ULN, eGFR < 60, or unstable heart disease.
- Regular alcohol consumption
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Proliverenol Supplementation 1000 mg with standard Therapy of DM
Participants in this arm will receive Proliverenol supplementation at a dose of 1000 mg twice daily for duration 12 weeks and standard theraphy (rapid-acting insulin three times a day, basal insulin once a day, or metformin 500 mg three times a day, or sitagliptin 50 mg twice a day, or gliclazide MR 60 mg once a day) |
This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes." |
|
Aktiv komparator: Patients receive standard of care treatment only
rapid-acting insulin three times daily, basal insulin once daily, or metformin 500 mg three times daily, or sitagliptin 50 mg twice daily, or gliclazide MR 60 mg once daily |
This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes." |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Visceral Adiposity Index (VAI) from baseline to week 12
Tidsramme: Baseline and week 12
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VAI is calculated using a formula that includes triglycerides, HDL, and body mass index. |
Baseline and week 12
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Change in HOMA-IR from baseline to week 12
Tidsramme: Baseline and week 12
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HOMA-IR is calculated from fasting glucose and fasting insulin levels. A higher score indicates worse insulin resistance. |
Baseline and week 12
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Change in C-Peptide from baseline to week 12
Tidsramme: Baseline and week 12
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C-peptide is measured through laboratory test results |
Baseline and week 12
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Change in Controlled Attenuation Parameter (CAP) from baseline to week 12
Tidsramme: Baseline and week 12
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CAP is measured using transient elastography to assess hepatic steatosis. |
Baseline and week 12
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in HbA1c levels from baseline to week 12
Tidsramme: Baseline and week 12
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HbA1c is measured through laboratory test results |
Baseline and week 12
|
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Changes in fasting glucose levels from baseline to week 12
Tidsramme: Baseline and week 12
|
Fasting glucose is measured through laboratory test results |
Baseline and week 12
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Changes in 2-hour postprandial glucose levels from baseline to week 12
Tidsramme: Baseline and week 12
|
2-hour postprandial glucose is measured through laboratory test results |
Baseline and week 12
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DP04.03/DXVII.9.4/ETIK/13/2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
IPD-delingstidsramme
Immediately following publication, with no end date
Tilgangskriterier for IPD-deling
The following supporting information will be made available: Study Protocol and Statistical Analysis Plan. De-identified IPD and supporting documents will be available immediately following publication, with no end date. Researchers who provide a methodologically sound proposal may request access by contacting the corresponding author and signing a data access agreement. Data will be shared for any purpose related to the approved proposal."
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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