Prediabetic StateNCT04441216
Effects of TCM on Beta-cell Function and Insulin Resistance in High Risk Chinese Individuals for T2D (TCM_PDiab_P01)
A study testing Rhizoma Coptidis, Radix Astragali and Flos Lonicerae and Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix in people with Prediabetic State, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study involves prediabetes volunteers who are at high risk of developing diabetes, including those with family history of diabetes, metabolic syndrome, fatty liver, polycystic ovary syndrome and history of gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Rhizoma Coptidis, Radix Astragali and Flos Lonicerae and Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Aug 2020to Jun 2023
- Phase
- Interventional
- 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
- Individuals aged ≥18 years-70 years
- BMI≥18 kg/m2
- Chinese ethnicity
- Individuals with pre-diabetes based on 75 gram oral glucose tolerance test (OGTT) defined as impaired fasting glycemia (fasting plasma glucose (FPG): ≥5.6-6.9 mmol/L) and/or impaired glucose tolerance (IGT) (2-h PG: ≥7.8-11.0 mmol/L) -
- Plus at least one risk factor(s) from the following list:
- 2 components of the metabolic syndrome
Show all 17Show fewer
- Triglyceride≥1.7 mmol/L
- BP≥130/80 mmHg
- HDL-C<1.3 mmol/L in women or <1.1 mmol/L in men
- Waist circumference≥80 cm in women or ≥90 cm in men
- Fatty liver
- Diagnosis by ultrasound scan and/or
- Diagnosis by fibroscan and/or
- Diagnosis by ALT>35 IU/L in men and >24 IU/L in women
- History of diabetes in first degree relatives
- History of gestational diabetes mellitus
- History of polycystic ovary syndrome
Who cannot join
- Not willing to participate in this study or adhere to study procedures
- Significant medical history including but not limited to history of CVD, renal estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 and/or liver dysfunction (AST and/or ALT≥3 times upper limit of normal)
- History of drug abuse or excessive alcohol intake based on investigator judgment
- Dehydration, diarrhea or vomiting at the time of recruitment
- Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment
- Subjects with blood haemoglobin outside the normal range (male: 13.5-17.5 g/dl and female: 12-15.5 g/dl)
Show all 16Show fewer
- Subjects who have donated blood in the 3 months prior to the study and/or plan to donate blood during the study period
- Current use of dietary supplements or health products affecting glycose or galactose metabolism or body weight in previous 1 month before first dosing.
- Breast feeding, pregnant women or women with plans for pregnancy
- Any conditions considered unsuitable by the investigators
- Subjects with use of Warfarin
- Subjects with known G6PD deficiency or known history of herb-drug interactions
- Known history of diabetes mellitus and/or HbA1c >= 6.5%.
- Usage of glucose lowering drugs and/or weight loss drugs currently or within 1 month before first dosing
- Previous metabolic surgery
- Known history of thyroid disorders
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Juliana Chan, 35053138, jchan@cuhk.edu.hk
About this study
Official title: Effects of a Novel Formulation of Traditional Chinese Medicine (TCM) For Prevention of Type 2 Diabetes (T2D)
This study involves prediabetes volunteers who are at high risk of developing diabetes, including those with family history of diabetes, metabolic syndrome, fatty liver, polycystic ovary syndrome and history of gestational diabetes. They will take a 12-week course of formula: a) JinQi JiangTang Fang (JQJT) including Coptidis Rhizoma, Astragali Radix and Lonicerae Japonicae Flos, b) combined the ingredients of JQJT and Ophiopogonis Radix to make up a novel CM, Jin Mai Fang (JM); to evaluate the effectiveness of Chinese Medicine in preventing diabetes in a controlled setting in order to better understand their actions. They will be followed up for another 12 weeks after the treatment to evaluate the improvement in glucose tolerance of the formula.
Read the detailed description
In China, 10% of adults have diabetes and 30% of people have prediabetes. In Hong Kong, 2 in 100 adults develop pre-diabetes every year and in 2014, 9% of adults have prediabetes. People with prediabetes have increased risk of cardiovascular disease and development of diabetes. Once developed, diabetes is associated with loss of 4-10 years of life depending on age of onset and 2-3 fold increased risk of cardiovascular, kidney and cancer events.
Early detection and intervention of pre-diabetes will prevent progression from pre-diabetes to diabetes and reduce the risk of complications of diabetes. This focus on prevention concords with the concept of 'Zhi-Wei-Bing' in Chinese Medicine (CM). This is not only an important philosophy of CM but also a unique feature of Chinese culture. The 'Zhi-Wei-Bing' philosophy includes disease prevention, treatment, and rehabilitation.
Insulin is secreted by the beta-cells of the pancreas which is the only hormone that can reduce blood glucose. People with diabetes have fewer pancreatic beta-cells than those without diabetes. Chinese Medicine contains multiple herbs which have been used in China for thousands of years. These herbal mixtures may alter the expression of these proteins which can lead to many biological effects including the possible benefits in reducing the risk of diabetes in high risk subjects.
JinQi JiangTang Fang (JQJT) contains extracts from three herbs including Coptidis Rhizoma, Astragali Radix and Lonicerae Japonicae Flos and is one of the most popular formulae used by CMP for prevention of diabetes. The sustained blood glucose lowering effects of JQJT in male Zucker diabetic fatty rats. On multiomic analysis, the investigators observed concerted expression changes in a gene-gene network involving mRNA, miRNA and proteins implicated in fat metabolism and cell cycles.
In this study, the investigators have combined the ingredients of JQJT and Ophiopogonis Radix (Maidong) to make up a novel CM formula, Jin Mai Fang (JM). According to TCM theory, Maidong nourishes the yin, promotes body fluid production, moistens the lung, eases the mind and clears away heart fire. The polysaccharide-rich extract of Maidong (0.06-240 mg/ml) has been shown to inhibit glucose absorption into the intestinal brush border membrane vesicles, reduce the activity of α-glucosidase and improve the activity of NIT-1 cells damaged by streptozotocin. These combined effects of inhibition of carbohydrate digestion and absorption and protection of the pancreatic islet cells provide a strong rationale for its use to prevent diabetes. The subjects will take a 12-week course of formula and they will be followed up for another 12 weeks after the treatment to evaluate the improvement in glucose tolerance of the formula.
- Conditions
- Prediabetic State
- Being tested
- Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix
- Keywords
- Prediabetes, Chinese Medicine
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhizoma Coptidis, Radix Astragali and Flos LoniceraeOther
granule
Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis RadixOther
granule
| Study group | Role | What they receive |
|---|---|---|
| Consultation only | No intervention | Review by Chinese Medicine practitioner only |
| JinQi JiangTang Fang | Active comparator | JinQi JiangTang Fang (Rhizoma Coptidis, Radix Astragali and Flos Lonicerae) Receives: Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae |
| JM-ELD | Active comparator | JQJT plus extra low dose Ophiopogonis Radix Receives: Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix |
| JM-LD | Active comparator | JQJT plus low doses Ophiopogonis Radix Receives: Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group differences in glycemic excursion during 75g OGTT as indicated by area under the curve (AUC) plasma glucose concentration during 12-week on-treatment and 12-week off treatment period
Plasma glucose during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Secondary outcomes (9)
Between group differences in insulin resistance (HOMA-IR),as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period
Plasma insulin during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in beta-cell function (HOMA-beta) as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period
Plasma insulin during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in quantitative insulin sensitivity check index (QUICKI) as indicated by during 12-week on-treatment and 12-week off treatment period
Plasma insulin during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in insulinogenic index as indicated by during 12-week on-treatment and 12-week off treatment period
Plasma insulin during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in vital sign during 12-week on-treatment and 12-week off treatment period
Measure blood pressure at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in body weight during 12-week on-treatment and 12-week off treatment period
Measure body weight at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in renal function during 12-week on-treatment and 12-week off treatment period
Measure renal function test by measuring Serum creatinine test at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Between group differences in liver function during 12-week on-treatment and 12-week off treatment period
Measure liver function test by measuring the change of Alanine transaminase (ALT) test at baseline, after 12 weeks treatment and 12 weeks of treatment period
Measured: 24 weeks
Prevalence of euglycaemic chinese subject after 12-week on-treatment and 12-week off treatment period
investigate the proportion of reversal from pre-diabetes to euglycaemia by assessing number euglycaemic subject after 12 weeks on treatment and 12 weeks off treatment period
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start2 Aug 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441216
- Sponsor's protocol ID
- CRE-2019.601
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Formulation of Traditional Chinese Medicine (TCM) For Prevention of Type 2 Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT04441216
- Acronym / sponsor ID
- CRE-2019.601
- Conditions
- Prediabetic State
- Keywords
- Prediabetes, Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Jun 2020 (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.
This study involves prediabetes volunteers who are at high risk of developing diabetes, including those with family history of diabetes, metabolic syndrome, fatty liver, polycystic ovary syndrome and history of gestational diabetes. They will take a 12-week course of formula: a) JinQi JiangTang Fang (JQJT) including Coptidis Rhizoma, Astragali Radix and Lonicerae Japonicae Flos, b) combined the ingredients of JQJT and Ophiopogonis Radix to make up a novel CM, Jin Mai Fang (JM); to evaluate the effectiveness of Chinese Medicine in preventing diabetes in a controlled setting in order to better understand their actions. They will be followed up for another 12 weeks after the treatment to evaluate the improvement in glucose tolerance of the formula.
Detailed description
In China, 10% of adults have diabetes and 30% of people have prediabetes. In Hong Kong, 2 in 100 adults develop pre-diabetes every year and in 2014, 9% of adults have prediabetes. People with prediabetes have increased risk of cardiovascular disease and development of diabetes. Once developed, diabetes is associated with loss of 4-10 years of life depending on age of onset and 2-3 fold increased risk of cardiovascular, kidney and cancer events.
Early detection and intervention of pre-diabetes will prevent progression from pre-diabetes to diabetes and reduce the risk of complications of diabetes. This focus on prevention concords with the concept of 'Zhi-Wei-Bing' in Chinese Medicine (CM). This is not only an important philosophy of CM but also a unique feature of Chinese culture. The 'Zhi-Wei-Bing' philosophy includes disease prevention, treatment, and rehabilitation.
Insulin is secreted by the beta-cells of the pancreas which is the only hormone that can reduce blood glucose. People with diabetes have fewer pancreatic beta-cells than those without diabetes. Chinese Medicine contains multiple herbs which have been used in China for thousands of years. These herbal mixtures may alter the expression of these proteins which can lead to many biological effects including the possible benefits in reducing the risk of diabetes in high risk subjects.
JinQi JiangTang Fang (JQJT) contains extracts from three herbs including Coptidis Rhizoma, Astragali Radix and Lonicerae Japonicae Flos and is one of the most popular formulae used by CMP for prevention of diabetes. The sustained blood glucose lowering effects of JQJT in male Zucker diabetic fatty rats. On multiomic analysis, the investigators observed concerted expression changes in a gene-gene network involving mRNA, miRNA and proteins implicated in fat metabolism and cell cycles.
In this study, the investigators have combined the ingredients of JQJT and Ophiopogonis Radix (Maidong) to make up a novel CM formula, Jin Mai Fang (JM). According to TCM theory, Maidong nourishes the yin, promotes body fluid production, moistens the lung, eases the mind and clears away heart fire. The polysaccharide-rich extract of Maidong (0.06-240 mg/ml) has been shown to inhibit glucose absorption into the intestinal brush border membrane vesicles, reduce the activity of α-glucosidase and improve the activity of NIT-1 cells damaged by streptozotocin. These combined effects of inhibition of carbohydrate digestion and absorption and protection of the pancreatic islet cells provide a strong rationale for its use to prevent diabetes. The subjects will take a 12-week course of formula and they will be followed up for another 12 weeks after the treatment to evaluate the improvement in glucose tolerance of the formula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consultation only | No intervention | –Review by Chinese Medicine practitioner only |
| JinQi JiangTang Fang | Active comparator | Other: Rhizoma Coptidis, Radix Astragali and Flos LoniceraeJinQi JiangTang Fang (Rhizoma Coptidis, Radix Astragali and Flos Lonicerae) |
| JM-ELD | Active comparator | Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis RadixJQJT plus extra low dose Ophiopogonis Radix |
| JM-LD | Active comparator | Other: Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis RadixJQJT plus low doses Ophiopogonis Radix |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Individuals aged ≥18 years-70 years
- BMI≥18 kg/m2
- Chinese ethnicity
- Individuals with pre-diabetes based on 75 gram oral glucose tolerance test (OGTT) defined as impaired fasting glycemia (fasting plasma glucose (FPG): ≥5.6-6.9 mmol/L) and/or impaired glucose tolerance (IGT) (2-h PG: ≥7.8-11.0 mmol/L) -
- Plus at least one risk factor(s) from the following list:
Key exclusion criteria (16 listed)
- Not willing to participate in this study or adhere to study procedures
- Significant medical history including but not limited to history of CVD, renal estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 and/or liver dysfunction (AST and/or ALT≥3 times upper limit of normal)
- History of drug abuse or excessive alcohol intake based on investigator judgment
- Dehydration, diarrhea or vomiting at the time of recruitment
- Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment
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 |
|---|---|---|
| Rhizoma Coptidis, Radix Astragali and Flos Loniceraegranule | Other | JinQi JiangTang Fang |
| Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radixgranule | Other | JM-ELD, JM-LD |
Primary outcome
Between-group differences in glycemic excursion during 75g OGTT as indicated by area under the curve (AUC) plasma glucose concentration during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Plasma glucose during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period
9 secondary outcomes
Between group differences in insulin resistance (HOMA-IR),as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in beta-cell function (HOMA-beta) as indicated by area under the curve (AUC) plasma insulin during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in quantitative insulin sensitivity check index (QUICKI) as indicated by during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in insulinogenic index as indicated by during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in vital sign during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in body weight during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in renal function during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Between group differences in liver function during 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Prevalence of euglycaemic chinese subject after 12-week on-treatment and 12-week off treatment period
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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 study testing Rhizoma Coptidis, Radix Astragali and Flos Lonicerae and Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix in people with Prediabetic State, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 17 inclusion and 16 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 20 Jul 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 Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group differences in glycemic excursion during 75g OGTT as indicated by area under the curve (AUC) plasma glucose concentration during 12-week on-treatment and 12-week off treatment period (time frame: 24 weeks). 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 20 Jul 2022.