Diabetic Neuropathy, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus Type 2, Functional Food, Gynura procumbens, Glycemic Control, Insulin Resistance, Diabetic Foot Ulcer Prevention
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 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.
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 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.
Interventions
DIETARY_SUPPLEMENTGlucoBites (with Gynura procumbens)
Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
DIETARY_SUPPLEMENTControl Cookies (without Gynura procumbens)
Participants consume 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor to the GlucoBites cookies but do not contain Gynura procumbens.
Sponsors
Andina Setyawati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This randomized controlled trial uses a parallel assignment model with two study arms. Participants will be randomly allocated to either the intervention group receiving GlucoBites functional cookies containing Gynura procumbens or the control group receiving standard diabetes care. Both groups will be followed simultaneously for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose (FBG) | 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 | 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). |
| MMP-9/TIMP-1 Ratio | 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). |
| Ankle-Brachial Index (ABI) | 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). |
Countries
Indonesia
Contacts
Primary ContactAndina Setyawati, Dr
Outcome results
None listed