PrediabetesPhase 2NCT05126251
Tangningtongluo Tablet for People With Prediabetes
A Phase 2 study testing Tangningtongluo tablet and lifestyle intervention in people with Prediabetes, run by Beijing University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Tangningtongluo tablet and lifestyle intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2021to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jin Li, MD, +865922137569, xdfyec@sina.com
About this study
Official title: Efficacy and Safety of Tangningtongluo Tablet in People With Prediabetes : a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- Tangningtongluo tablet, lifestyle intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangningtongluo tabletDrug
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))
lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity index
The change of Matsuda index value from baseline calculated according to three-point OGTT (0, 30min, 120min).
Measured: 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.
Measured: Baseline, 12weeks, 24weeks(if necessary)
HbA1c
The change of HbA1c from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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；
Measured: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: PAI-1
Changes of PAI-1 from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: NO
Changes of NO from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Vascular endothelial function indexes: ET-1
Changes of ET-1 from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: TNF-α
Changes of TNF-α from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-6
Changes of IL-6 from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-2
Changes of IL-2 from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: IL-1β
Changes of IL-1β from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: adiponectin
Changes of adiponectin from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: hsCRP
Changes of hsCRP from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Inflammatory factor index: FGF-21
Changes of FGF-21 from baseline
Measured: Baseline, 12weeks, 24weeks(if necessary)
Urinary albumin creatinine ratio (UACR)
Changes of Urinary albumin creatinine ratio (UACR) from baseline
Measured: 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
Measured: Baseline, 12weeks, 24weeks(if necessary)
Carotid artery intima-media thickness
Changes of Carotid artery intima-media thickness measured by an ultrasound scanner from baseline
Measured: 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.
Measured: 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.
Measured: Baseline, 12weeks, 24weeks(if necessary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start13 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuyu Yang, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126251
- Sponsor's protocol ID
- GZY-KJS-2021-006
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tangningtongluo Tablet in People With Prediabetes : a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05126251
- Acronym / sponsor ID
- GZY-KJS-2021-006
- Conditions
- Prediabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tangningtongluo group | Experimental | Drug: Tangningtongluo tablet, Behavioral: lifestyle intervention1. 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 |
| Placebo group | Placebo comparator | Behavioral: lifestyle interventionPlacebo 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tangningtongluo tabletTangningtongluo 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)) | Drug | Tangningtongluo group |
| lifestyle interventionAvoid 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. | Behavioural | Placebo group, Tangningtongluo group |
Primary outcome
Insulin sensitivity index
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The change of Matsuda index value from baseline calculated according to three-point OGTT (0, 30min, 120min).
Pancreatic β-cell function indicators
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The change of Pancreatic β-cell function indicators from baseline according to insulin source index and insulin disposal index.
HbA1c
Time frame: Baseline, 12weeks, 24weeks(if necessary)
The change of HbA1c from baseline
Metabolic index
Time frame: 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
Time frame: 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
The rate of blood glucose reversed to normal
Time frame: 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
Changes in the proportion of subjects diagnosed with fatty liver from baseline
Time frame: 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: PAI-1
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of PAI-1 from baseline
Vascular endothelial function indexes: NO
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of NO from baseline
Vascular endothelial function indexes: ET-1
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of ET-1 from baseline
Inflammatory factor index: TNF-α
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of TNF-α from baseline
Inflammatory factor index: IL-6
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-6 from baseline
Inflammatory factor index: IL-2
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-2 from baseline
Inflammatory factor index: IL-1β
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of IL-1β from baseline
Inflammatory factor index: adiponectin
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of adiponectin from baseline
Inflammatory factor index: hsCRP
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of hsCRP from baseline
Inflammatory factor index: FGF-21
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of FGF-21 from baseline
Urinary albumin creatinine ratio (UACR)
Time frame: Baseline, 12weeks, 24weeks(if necessary)
Changes of Urinary albumin creatinine ratio (UACR) from baseline
Incidence of diabetic retinopathy
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tangningtongluo tablet and lifestyle intervention in people with Prediabetes, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei Han (+86 13401131731, hanmeizoujin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity index (time frame: Baseline, 12weeks, 24weeks(if necessary)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.