Clinical trial NCT05126251: Tangningtongluo Tablet for People With Prediabetes
Official title: Efficacy and Safety of Tangningtongluo Tablet in People With Prediabetes : a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prediabetes
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Insulin sensitivity index
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Pancreatic β-cell function indicators
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: HbA1c
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Metabolic index
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Diabetes incidence rate
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: The rate of blood glucose reversed to normal
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Changes in the proportion of subjects diagnosed with fatty liver from baseline
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Vascular endothelial function indexes: PAI-1
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Vascular endothelial function indexes: NO
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Vascular endothelial function indexes: ET-1
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: TNF-α
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: IL-6
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: IL-2
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: IL-1β
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: adiponectin
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: hsCRP
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Inflammatory factor index: FGF-21
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Urinary albumin creatinine ratio (UACR)
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Incidence of diabetic retinopathy
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: Carotid artery intima-media thickness
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: The scores of prediabetes symptom questionnaire
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
measure: The scores of short form health survey (SF-36)
timeFrame: Baseline, 12weeks, 24weeks(if necessary)
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: