RecruitingNCT07928661ClinicalTrials.gov record

Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 Diabetes

Diabetes Mellitus, Type 2

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2
Age range: 30 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 50 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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."

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

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)

Drug: Proliverenol

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

Drug: Proliverenol

Proliverenol DRUG

This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes."

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