Tangningtongluo Tablet for People With Prediabetes

NCT05126251 | Unknown Phase 2

• 1 other identifier: GZY-KJS-2021-006
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (22)

• Insulin sensitivity index

  The change of Matsuda index value from baseline calculated according to three-point OGTT (0, 30min, 120min).

  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.

  Baseline, 12weeks, 24weeks(if necessary)

• HbA1c

  The change of HbA1c from baseline

  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

  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

  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

  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；

  Baseline, 12weeks, 24weeks(if necessary)

• Vascular endothelial function indexes: PAI-1

  Changes of PAI-1 from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Vascular endothelial function indexes: NO

  Changes of NO from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Vascular endothelial function indexes: ET-1

  Changes of ET-1 from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: TNF-α

  Changes of TNF-α from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: IL-6

  Changes of IL-6 from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: IL-2

  Changes of IL-2 from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: IL-1β

  Changes of IL-1β from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: adiponectin

  Changes of adiponectin from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: hsCRP

  Changes of hsCRP from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Inflammatory factor index: FGF-21

  Changes of FGF-21 from baseline

  Baseline, 12weeks, 24weeks(if necessary)

• Urinary albumin creatinine ratio (UACR)

  Changes of Urinary albumin creatinine ratio (UACR) from baseline

  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

  Baseline, 12weeks, 24weeks(if necessary)

• Carotid artery intima-media thickness

  Changes of Carotid artery intima-media thickness measured by an ultrasound scanner from baseline

  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.

  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.

  Baseline, 12weeks, 24weeks(if necessary)

Study Arms (2)

Tangningtongluo group

EXPERIMENTAL

1. 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. 2. Lifestyle intervention

Drug: Tangningtongluo tablet; Behavioral: lifestyle intervention

Placebo group

PLACEBO COMPARATOR

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

Behavioral: lifestyle intervention

Interventions

Tangningtongluo tablet DRUG

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))

Tangningtongluo group

lifestyle intervention BEHAVIORAL

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.

Placebo group; Tangningtongluo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Interventions

tangningtongluo

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mei Han

CONTACT

+86 13401131731; hanmeizoujin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 18, 2021
• Study Start: December 13, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

CN (1)