Clinical trial NCT06494683: Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus
Official title: Efficacy and Safety of Pueraria Lobata Radix As an Adjuvant Treatment for Type 2 Diabetes Mellitus: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Pueraria lobata radix
Ge Gen
Type 2 diabetes mellitus
Randomized controlled trial
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Nanchang University
First posted: 2024-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline, Week 4 and Week 8
measure: HbA1c response rate
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Fasting blood glucose
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Two-hour postprandial glucose
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Fasting C-peptide
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Body mass index
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Total cholesterol
timeFrame: Baseline and Week 12
measure: Triglycerides
timeFrame: Baseline and Week 12
measure: High-density lipoprotein cholesterol
timeFrame: Baseline and Week 12
measure: Low-density lipoprotein cholesterol
timeFrame: Baseline and Week 12
measure: Non-high-density lipoprotein cholesterol
timeFrame: Baseline and Week 12
measure: Systolic blood pressure
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Diastolic blood pressure
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Severity of diabetes symptoms
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Diabetes Specific Quality of Life questionnaire scores
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Hypoglycemic drug dose
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Incidence of any adverse events
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Incidence of severe adverse events
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Incidence of treatment-related adverse events
timeFrame: Baseline, Week 4, Week 8 and Week 12
measure: Incidence of individual adverse events
timeFrame: Baseline, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
state: Jiangxi
Study officials:
affiliation: Jiangxi University of Traditional Chinese Medicine
name: Xu Zhou, M.D
role: PRINCIPAL_INVESTIGATOR
References: