A Phase 2 interventional study of Proliverenol in Diabetes Mellitus, Type 2, sponsored by Universitas Sriwijaya. Recruiting at 1 site in Indonesia. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Universitas Sriwijaya · Phase 2, Interventional, and Treatment
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."
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Universitas Sriwijaya is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes."
Change in the Visceral Adiposity Index (VAI) from baseline to week 12
VAI is calculated using a formula that includes triglycerides, HDL, and body mass index.
Time frame: Baseline and week 12
Change in HOMA-IR from baseline to week 12
HOMA-IR is calculated from fasting glucose and fasting insulin levels. A higher score indicates worse insulin resistance.
Time frame: Baseline and week 12
Change in C-Peptide from baseline to week 12
C-peptide is measured through laboratory test results
Time frame: Baseline and week 12
Change in Controlled Attenuation Parameter (CAP) from baseline to week 12
CAP is measured using transient elastography to assess hepatic steatosis.
Time frame: Baseline and week 12
Changes in HbA1c levels from baseline to week 12
HbA1c is measured through laboratory test results
Time frame: Baseline and week 12
Changes in fasting glucose levels from baseline to week 12
Fasting glucose is measured through laboratory test results
Time frame: Baseline and week 12
Changes in 2-hour postprandial glucose levels from baseline to week 12
2-hour postprandial glucose is measured through laboratory test results
Time frame: Baseline and week 12
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Immediately following publication, with no end date
Access criteria: 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."
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitas Sriwijaya