Efficacy of GlucoBites Functional Cookies Containing Gynura Procumbens on Glycemic Control, Insulin Resistance, and Prevention of Diabetic Foot Ulcer Risk in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- MMP-9/TIMP-1 Ratio
研究概览
简要总结
The goal of this randomized controlled trial is to learn if GlucoBites functional cookies containing Gynura procumbens can help improve blood sugar control and lower the risk of diabetic foot ulcers in adults with type 2 diabetes.
The main questions are:
- Do GlucoBites cookies lower fasting blood glucose and HbA1c?
- Do GlucoBites cookies improve insulin resistance and vascular health?
- Can GlucoBites reduce early signs that may lead to diabetic foot ulcers?
Researchers will compare:
- Intervention group: participants will eat 4 GlucoBites cookies every day for 12 weeks.
- Control group: participants will continue standard diabetes care without GlucoBites.
Participants will:
- Visit the community health center for blood tests and foot health checks.
- Be monitored for blood sugar, insulin resistance, lipid profile, and vascular function.
- Be assessed for early risk of diabetic foot ulcer development.
This study will help determine if a functional food innovation can support diabetes care and prevent complications.
详细描述
Type 2 diabetes mellitus is a chronic condition associated with serious complications, including neuropathy and diabetic foot ulcers. Many people in Indonesia still struggle with poor blood sugar control despite standard treatments. This highlights the need for safe, affordable, and culturally acceptable nutritional strategies.
This study is testing GlucoBites, a functional cookie made with Gynura procumbens, a traditional medicinal plant with potential glucose-lowering and vascular protective properties. Researchers want to see if adding GlucoBites to daily care can improve blood sugar control and reduce early risk factors linked to diabetic foot ulcer development.
The study will help determine whether functional food innovation can be integrated into community-based diabetes management and offer a preventive approach to reduce long-term complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants in both arms receive visually identical cookies. The experimental cookies contain Gynura procumbens extract, while the control cookies do not. Packaging, appearance, weight, and flavor are matched. Randomization codes are held by an independent pharmacist/allocator; care providers and outcomes assessors are blinded to group assignment. Unblinding will occur only after database lock or for safety reasons.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20-70 years.
- •Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria.
- •HbA1c ≥ 7%.
- •At risk of diabetic foot ulcer (ABI < 0.9 or early neuropathy signs).
- •Willing to consume study cookies and comply with study protocol.
- •Provided written informed consent.
排除标准
- •Current use of herbal supplements or functional foods containing Gynura procumbens.
- •Presence of active diabetic foot ulcer or severe infection.
- •Severe cardiovascular, renal (eGFR < 30 mL/min/1.73 m²), or hepatic impairment.
- •Pregnancy or breastfeeding.
- •Known allergy to ingredients in study cookies.
- •Participation in another clinical trial within the last 3 months.
结局指标
主要结局
MMP-9/TIMP-1 Ratio
时间窗: Baseline and 12 weeks after intervention
The ratio of matrix metalloproteinase-9 (MMP-9) to tissue inhibitor of metalloproteinase-1 (TIMP-1) in serum, quantified using ELISA. The ratio is calculated by dividing MMP-9 (ng/mL) by TIMP-1 (ng/mL). The endpoint is the change in MMP-9/TIMP-1 ratio from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Fasting Blood Glucose (FBG)
时间窗: Baseline and 12 weeks after intervention
Fasting blood glucose (FBG, mg/dL) measured from venous blood after 8-10 hours of fasting using standardized laboratory methods. The primary endpoint is the change from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Change in HOMA-IR
时间窗: Baseline and 12 weeks after intervention
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose (mg/dL) and fasting insulin (µIU/mL) using the formula: \[fasting insulin × fasting glucose / 405\]. The endpoint is the change in HOMA-IR from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
Ankle-Brachial Index (ABI)
时间窗: Baseline and 12 weeks after intervention
The ankle-brachial index (ABI) is calculated as the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Measurements are obtained using a handheld Doppler device. ABI will be used as an indicator of peripheral vascular function and early risk of diabetic foot ulcer. The endpoint is the change in ABI from baseline to Week 12, comparing the GlucoBites group (with Gynura procumbens) and the control group (without Gynura procumbens).
次要结局
未报告次要终点
研究者
Andina Setyawati
Principal Investigator
Hasanuddin University