Efficacy and Safety of Tangningtongluo Tablet in People With Prediabetes : a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pancreatic β-cell function indicators
研究概览
简要总结
Prediabetes is an intermediate transition to hyperglycemia between normal blood glucose and diabetes, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT)and the presence of a combination of the two.
At present, the prediabetes population in China is very large. Timely detection of this sub-health population and effective intervention are the key to prevent or delay diabetes and related complications. Basic research showed that Tangningtongluo had a good hypoglycemic effect on db/db diabetic mice and STZ induced diabetic rats, and could alleviate pancreatic islet destruction and insulin resistance to some extent.
In this study, the therapeutic effects of Tangningtongluo pian provided by Guizhou bailing Enterprise Group Pharmaceutical Co., Ltd on patients with prediabetes was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Tangningtongluo pian in the treatment of prediabetes . In the design of this trial, the therapeutic effects and safety of Tangningtongluo pian in the treatment of prediabetes were evaluated with Tangningtongluo pian in the treatment group and placebo in the control group.
详细描述
Prediabetes is an intermediate transition to hyperglycemia between normal blood glucose and diabetes, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT)and the presence of a combination of the two.
At present, the prediabetes population in China is very large. Timely detection of this sub-health state and effective intervention are the key to prevent or delay diabetes and related complications. Prediabetes is mainly IGT, and its core pathophysiological basis is insulin resistance. The existing western medicine can improve insulin resistance to varying degrees, but it can not prevent diabetes. Tangning Tongluo is an in-hospital preparation of Guizhou bailing. It is used for diabetes caused by deficiency of Qi and Yin. The symptoms include thirst, drinking, overeating, polyuria, weight loss, shortness of breath, fatigue, hand, foot and heart heat and blurred vision; Type 2 diabetes and diabetic retinopathy see the above syndrome.Basic research showed that Tang Ning Tong Luo had a good hypoglycemic effect on db/db diabetic mice and STZ induced diabetic rats, and could alleviate pancreatic islet destruction and insulin resistance to some extent. In addition, the drug has a certain retarding effect on diabetic nephropathy animal models [renal function, renal pathology, urinary protein (3+ to 2+)] and fundus lesions, and also improves liver function and myocardial enzymes. Further mechanism studies show that Tangning Tongluo exerts its anti-inflammatory, hypoglycemic and obesity induced insulin resistance effects by up regulating the expression of sequence binding protein (SBP) 2 in macrophages ; In addition, mip1 was inhibited γ/ CCR1 axis improves in diabetic retinopathy.It is speculated that the drug may be effective for prediabetes In this study, the therapeutic effects of Tangningtongluo pian provided by Guizhou bailing Enterprise Group Pharmaceutical Co., Ltd on patients with prediabetes was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Tangningtongluo pian in the treatment of prediabetes .
In the design of this trial, the therapeutic effects and safety of Tangningtongluo pian in the treatment of prediabetes were evaluated with Tangningtongluo pian in the treatment group and placebo in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FPG 5.6mmol/L~6.9mmol/L or OGTT 2H blood glucose 7.8mmol/L~11.0mmol/L or HbA1c 5.7%~6.4%, the above 3 indicators need to meet at least 2 items；
- •Age 18 ~ 70 years old (including boundary value);
- •Patients who voluntarily signed the informed consent and had conditional follow-up.
排除标准
- •Regularly take drugs affecting blood glucose within 1 month before screening, such as hypoglycemic drugs, glucocorticoids, niacin β- Adrenergic agonists, thyroid hormones, contraceptives, diazoxide, diuretics, phenytoin sodium γ- Interferon, etc;
- •Combined with various diseases that may significantly shorten life expectancy, such as malignant tumors, severe organ failure and so on;
- •Combined with various diseases that may seriously affect the subject's participation in the test, such as psychosis, serious motor system abnormalities, etc;
- •Combined ALT or ast > 2.5 times the upper limit of normal value, or serum creatinine > 1.5mg/dl;
- •Allergic to the test drug or its components;
- •Pregnant or lactating women, or women who have pregnancy plans from the study period to 3 months after the last administration, or men who are unwilling to take a medically recognized effective non drug contraceptive measure.
- •Chronic diarrhea caused by inflammatory bowel disease and irritable bowel syndrome;
- •The investigator believes that it is inappropriate to be included in this trial.
研究组 & 干预措施
Tangningtongluo group
- Tangningtongluo tablet will be used in this arm. Patients should take medicine with warm water about 30min after meal. (1.6g/time, twice a day) According to the above usage and dosage, take 12 weeks continuously. After 12 weeks, the researcher decided whether the subjects entered the extended trial according to the wishes of the subjects, and continued to use the drug until 24 weeks.
- Lifestyle intervention
干预措施: Tangningtongluo tablet (Drug)
Tangningtongluo group
- Tangningtongluo tablet will be used in this arm. Patients should take medicine with warm water about 30min after meal. (1.6g/time, twice a day) According to the above usage and dosage, take 12 weeks continuously. After 12 weeks, the researcher decided whether the subjects entered the extended trial according to the wishes of the subjects, and continued to use the drug until 24 weeks.
- Lifestyle intervention
干预措施: lifestyle intervention (Behavioral)
Placebo group
Placebo of Tangningtongluo tablet will be used in this arm. Patients should take medicine with warm water about 30min after meal. (2.0g/time, twice a day) According to the above usage and dosage, take 12 weeks continuously. After 12 weeks, the researcher decided whether the subjects entered the extended trial according to the wishes of the subjects, and continued to use the drug until 24 weeks.
2） Lifestyle intervention
干预措施: lifestyle intervention (Behavioral)
结局指标
主要结局
Pancreatic β-cell function indicators
时间窗: Baseline, 12weeks, 24weeks(if necessary)
The change of Pancreatic β-cell function indicators from baseline according to insulin source index and insulin disposal index.
Metabolic index
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of fasting blood glucose, OGTT 2H blood glucose,body weight, BMI, waist circumference, waist hip ratio, blood lipid (TC, TG, HDL-C, LDL-C), free fatty acid and blood uric acid from baseline
Diabetes incidence rate
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Diabetes incidence rate of experimental group=Number of people diagnosed with diabetes/The sample size of experimental group Diabetes incidence rate of placebo group=Number of people diagnosed with diabetes/The sample size of placebo group
Insulin sensitivity index
时间窗: Baseline, 12weeks, 24weeks(if necessary)
The change of Matsuda index value from baseline calculated according to three-point OGTT (0, 30min, 120min).
HbA1c
时间窗: Baseline, 12weeks, 24weeks(if necessary)
The change of HbA1c from baseline
The rate of blood glucose reversed to normal
时间窗: Baseline, 12weeks, 24weeks(if necessary)
The rate of blood glucose reversed to normal in experimental group=Number of people blood glucose reversed to normal/The sample size of experimental group The rate of blood glucose reversed to normal in placebo group=Number of people blood glucose reversed to normal/The sample size of placebo group
Vascular endothelial function indexes: PAI-1
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of PAI-1 from baseline
Vascular endothelial function indexes: NO
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of NO from baseline
Changes in the proportion of subjects diagnosed with fatty liver from baseline
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes in the proportion of the experimental group=The proportion of subjects diagnosed with fatty liver after treatment in the experimental group-The proportion of subjects diagnosed with fatty liver in the experimental group in baseline； Changes in the proportion of the placebo group=The proportion of subjects diagnosed with fatty liver after treatment in the placebo group-The proportion of subjects diagnosed with fatty liver in the placebo group in baseline；
Vascular endothelial function indexes: ET-1
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of ET-1 from baseline
Inflammatory factor index: TNF-α
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of TNF-α from baseline
Inflammatory factor index: IL-6
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-6 from baseline
Inflammatory factor index: IL-2
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-2 from baseline
Inflammatory factor index: IL-1β
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-1β from baseline
Inflammatory factor index: adiponectin
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of adiponectin from baseline
Inflammatory factor index: hsCRP
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of hsCRP from baseline
Inflammatory factor index: FGF-21
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of FGF-21 from baseline
Urinary albumin creatinine ratio (UACR)
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of Urinary albumin creatinine ratio (UACR) from baseline
Incidence of diabetic retinopathy
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Incidence of diabetic retinopathy of experimental group=Number of people diagnosed with diabetic retinopathy/The sample size of experimental group Incidence of diabetic retinopathy of placebo group=Number of people diagnosed with diabetic retinopathy/The sample size of placebo group
Carotid artery intima-media thickness
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of Carotid artery intima-media thickness measured by an ultrasound scanner from baseline
The scores of prediabetes symptom questionnaire
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of the score of prediabetes symptom questionnaire from baseline . This scale is self-made and includes 15 symptoms. Each symptom scores 0-3 points, and the total score is 45 points. The higher the score, the more severe the symptoms.
The scores of short form health survey (SF-36)
时间窗: Baseline, 12weeks, 24weeks(if necessary)
Changes of the MOS 36 item short form health survey (SF-36) scores from baseline，the minimum and maximum values of the survey are 156 and 37 respectively, and higher scores mean a better outcome.
次要结局
未报告次要终点
研究者
Shuyu Yang
Researcher
The First Affiliated Hospital of Xiamen University