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."
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
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South Sumatera
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Palembang, South Sumatera, 인도네시아, 30128
- 모병
- University of Sriwijaya Palembang
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연락하다:
- Dian Wijayanti, dr. Dian Wijayanti, SpPD
- 전화번호: +62811-7870-993
- 이메일: dyan.wijayanti@gmail.com
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수석 연구원:
- Zainal Fahmi, dr. Zainal Fahmi, SpPD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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." |
|
활성 비교기: 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." |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the Visceral Adiposity Index (VAI) from baseline to week 12
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in HbA1c levels from baseline to week 12
기간: Baseline and week 12
|
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
기간: Baseline and week 12
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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
기간: Baseline and week 12
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2-hour postprandial glucose is measured through laboratory test results |
Baseline and week 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DP04.03/DXVII.9.4/ETIK/13/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
IPD 공유 기간
Immediately following publication, with no end date
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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