Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes

Not Applicable

Completed

• Conditions: Type II Diabetes

• Registration Number: NCT06224803
• Lead Sponsor: Global Preventive Medicine Biotech Co., Ltd.

Brief Summary

At present, diabetic patients mainly use drugs to control blood sugar. However, drugs have side effects and the control effect varies among individuals. Even if diabetic patients can control their blood sugar well, long-term medication will still cause a series of complications, including retinopathy, nephropathy, diabetic foot, heart disease, etc. Vascular disease issues, etc.

This study will focus on the changes in HbA1c and blood sugar in patients with confirmed diabetes after taking "Dibifree®" food supplement.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-26
• Primary Completion: 2021-07-21
• Study Completion: 2022-01-18
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-13
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Age: 20 years old (inclusive) or above, gender is not restricted
2. Diagnosed with type 2 diabetes
3. HbA1c > 6.5%
4. Coagulation function and platelets are normal
5. Participants voluntarily join this treatment course and sign the informed consent form
6. Not taking other supplements containing blood sugar regulating properties for at least one month

Exclusion Criteria

1. Women who are pregnant, lactating or planning to have children
2. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.
3. Uncontrolled hypertension (>180/110 mmHG)
4. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases
5. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications.
6. GOT>4 times normal value; GPT>4 times normal value
7. Creatinine>4 times the highest normal value
8. Those who are determined by the project administrator to be unfit to participate in this clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Concentration of HbA1c	HbA1c was measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.	Hemoglobin A1c (HbA1c) levels were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.
Body Weight and BMI	Body weight and BMI were measured at baseline (V0) and at the end of the 7-month intervention (V7).	Changes in body weight and BMI between baseline (V0) and month 7 (V7) were analyzed using an unpaired t-test. Statistical analyses were conducted using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA), with p ≤ 0.05 considered statistically significant.

Secondary Outcome Measures

Name	Time	Method
Concentration of blood lipid	The measurement at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.	Total cholesterol, HDL-cholesterol, and LDL-cholesterol were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.
Concentration of Blood Sugar	measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.	AC \& PC blood sugar levels were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.
Kidney Function Parameters: BUN, Creatinine, and eGFR	Kidney function parameters measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.	Kidney Function Parameters were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.
Liver Function Parameters: GOT and GPT	Liver function parameters measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.	Liver Function Parameters were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

Trial Locations

Locations (1)

Global Preventive Medicine Biotech Co., Ltd.; 🇨🇳 New Taipei, Taiwan