Status:
NOT_YET_RECRUITING
GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
Lead Sponsor:
Andina Setyawati
Conditions:
Type 2 Diabetes Mellitus
Diabetic Neuropathy
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief 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 i...
Detailed Description
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT07151833
Start Date
September 20 2025
End Date
January 20 2026
Last Update
September 3 2025
Active Locations (1)
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1
Public Health Centre of Campagaloe
Bantaeng, South Sulawesi, Indonesia, 92411