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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Tangningtongluo Tablet 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. The present study shows that Tangningtongluo Tablet have certain hypoglycemic effects in diabetic animal models and diabetic patients, and may improve insulin sensitivity in diabetic mice.It is speculated that the drug may be effective for prediabetes. (0.4g/tablet,Plate(12 pills/plate ×3 plates/box))
Avoid overeating, avoid large intake of high-calorie, high-fat foods, live a regular life, avoid sitting for a long time, strengthen exercise and reduce weight.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGInsulin sensitivity index
The change of Matsuda index value from baseline calculated according to three-point OGTT (0, 30min, 120min).
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Pancreatic β-cell function indicators
The change of Pancreatic β-cell function indicators from baseline according to insulin source index and insulin disposal index.
Time frame: Baseline, 12weeks, 24weeks(if necessary)
HbA1c
The change of HbA1c from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Metabolic index
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
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Diabetes incidence rate
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
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The rate of blood glucose reversed to normal
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
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes in the proportion of subjects diagnosed with fatty liver from baseline
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；
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: PAI-1
Changes of PAI-1 from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: NO
Changes of NO from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: ET-1
Changes of ET-1 from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: TNF-α
Changes of TNF-α from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-6
Changes of IL-6 from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-2
Changes of IL-2 from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-1β
Changes of IL-1β from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: adiponectin
Changes of adiponectin from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: hsCRP
Changes of hsCRP from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: FGF-21
Changes of FGF-21 from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Urinary albumin creatinine ratio (UACR)
Changes of Urinary albumin creatinine ratio (UACR) from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Incidence of diabetic retinopathy
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
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Carotid artery intima-media thickness
Changes of Carotid artery intima-media thickness measured by an ultrasound scanner from baseline
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The scores of prediabetes symptom questionnaire
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.
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The scores of short form health survey (SF-36)
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.
Time frame: Baseline, 12weeks, 24weeks(if necessary)
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