Type 2 Diabetes Mellitus
Conditions
Keywords
Pueraria lobata radix, Ge Gen, Type 2 diabetes mellitus, Randomized controlled trial
Brief summary
As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM).
Detailed description
As a dietary herb, pueraria lobata radix (PLR) has been showed to have hypoglycemic effects in animal experiments. However, there is currently a lack of evidence from randomized controlled trials. Therefore, this randomized, double-blind, placebo-controlled trial aims to assess the efficacy and safety of PLR as an adjunctive treatment for type 2 diabetes mellitus (T2DM). T2DM is the most prevalent chronic metabolic disease. It has been noted in clinical practice that the limitations of conventional treatment methods, such as secondary failure and adverse reactions, continue to pose challenges for patients in managing their blood glucose levels, preventing them from achieving optimal glycemic control goals. Therefore, it is essential to search for more effective and safe complementary medications. PLR (Chinese name: Ge Gen) is the dried root of the leguminous plant kudzu (Pueraria lobata (Willd.) Ohwi). In China and other East Asian countries, PLR has been widely used to treat metabolic diseases, including T2DM. The chemical components of PLR include isoflavones, triterpenes, saponins, polysaccharides, coumarin compounds, and alkaloids, with isoflavones being the primary active ingredients of PLR. Multiple animal studies have shown that the main active components in isoflavones, such as puerarin, daidzein, and genistein, effectively increase serum insulin concentrations, lower blood glucose levels, and improve insulin resistance in diabetic mice. Puerarin injection has been widely used in China for the treatment of diabetes and its complications. PLR is classified as a medicinal and edible herb according to Chinese regulations, demonstrating good safety, with no reports of adverse reactions from long-term consumption in practice. However, there is currently a lack of randomized controlled trial evidence on the use of PLR for assisting in glycemic management. Therefore, this study aims to conduct a randomized controlled trial to evaluate the efficacy and safety of daily PLR treatment for adjunctive management of T2DM.
Interventions
DRUGPueraria lobata radix
The dose of Pueraria lobata radix granules is one sachet per day, 1.5g per sachet, which equivalent to 15 g of the original herb.
Sponsors
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
The First Affiliated Hospital of Nanchang University
Jiangxi University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of type 2 diabetes mellitus according to the International Diabetes Guidelines: fasting blood glucose (FBG) ≥ 126 mg/dl (7.0 mmol/l) or 2-hour postprandial blood glucose ≥ 200 mg/dL (11.1 mmol/l), or HbA1c ≥ 6.5% (48 mmol/mol). 2. Age between 18 and 80 years old. 3. Untreated patients or those currently receiving regular anti-diabetic medication therapy, including oral hypoglycemic drugs and insulin, with no restrictions on types or doses. 4. Blood glucose levels not effectively controlled in the three months prior to baseline screening: HbA1c between 6.5% and 10.5%. 5. Willingness to comply with dietary control requirements during the study. 6. Voluntary participation and signing of informed consent form.
Exclusion criteria
1. Type 1 diabetes, gestational diabetes, and special types of diabetes. 2. History of diabetic acute complications, including ketoacidosis, hyperosmolar coma, and lactic acidosis. 3. Pregnant or lactating women, or women planning pregnancy. 4. Allergy history to Pueraria lobata radix. 5. Severe dysfunction of vital organs such as heart, liver, and kidney, malignant tumors, or severe mental disorders. 6. Anticipated poor compliance or language communication impairments. 7. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline and Week 12 | Changes from baseline in HbA1c levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c response rate | Baseline, Week 4, Week 8 and Week 12 | Proportion of patients with HbA1c \< 7.0% |
| Fasting blood glucose | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in fasting blood glucose levels |
| Two-hour postprandial glucose | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in two-hour postprandial glucose levels |
| Fasting C-peptide | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in fasting C-peptide levels |
| Body mass index | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in body mass index |
| Total cholesterol | Baseline and Week 12 | Changes from baseline in total cholesterol levels |
| Triglycerides | Baseline and Week 12 | Changes from baseline in triglycerides levels |
| High-density lipoprotein cholesterol | Baseline and Week 12 | Changes from baseline in high-density lipoprotein cholesterol levels |
| Low-density lipoprotein cholesterol | Baseline and Week 12 | Changes from baseline in low-density lipoprotein cholesterol levels |
| HbA1c | Baseline, Week 4 and Week 8 | Changes from baseline in HbA1c levels |
| Systolic blood pressure | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in systolic blood pressure |
| Diastolic blood pressure | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in diastolic blood pressure |
| Severity of diabetes symptoms | Baseline, Week 4, Week 8 and Week 12 | Severity of diabetes symptoms will be scored using the Diabetes Symptom Grading Scale in the Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicines. |
| Diabetes Specific Quality of Life questionnaire scores | Baseline, Week 4, Week 8 and Week 12 | Quality of life will be measured using the Diabetes Specific Quality of Life questionnaire (DSQL). |
| Hypoglycemic drug dose | Baseline, Week 4, Week 8 and Week 12 | Changes from baseline in hypoglycemic drug dose |
| Incidence of any adverse events | Baseline, Week 4, Week 8 and Week 12 | An adverse event is defined as any medically induced harm, excluding those due to nature progression of diabetes mellitus. |
| Incidence of severe adverse events | Baseline, Week 4, Week 8 and Week 12 | Severe adverse events include adverse events that require hospitalization, induce prolonged hospitalization, disability, or impacts on work capacity, are life-threatening, or cause death. |
| Incidence of treatment-related adverse events | Baseline, Week 4, Week 8 and Week 12 | The causality of treatment and adverse events will be assessed by the Clinical Event Committee. |
| Incidence of individual adverse events | Baseline, Week 4, Week 8 and Week 12 | The main concern is hypoglycemia and gastrointestinal reactions. |
| Non-high-density lipoprotein cholesterol | Baseline and Week 12 | Changes from baseline in non-high-density lipoprotein cholesterol levels |
Countries
China
Contacts
Primary ContactXu Zhou, M.D
Outcome results
None listed