GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer… (NCT07151833) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
Indonesia126 participantsStarted 2025-09-20
Plain-language summary
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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting Blood Glucose (FBG)
Timeframe: Baseline and 12 weeks after intervention
2
Change in HOMA-IR
Timeframe: Baseline and 12 weeks after intervention
3
MMP-9/TIMP-1 Ratio
Timeframe: Baseline and 12 weeks after intervention
4
Ankle-Brachial Index (ABI)
Timeframe: Baseline and 12 weeks after intervention