Type 2 Diabetes Mellitus in ObeseNCT05072990
Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine
An observational study of Type 2 Diabetes Mellitus in Obese and Dyslipidemia Associated With Type II Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese, Dyslipidemia Associated With Type II Diabetes Mellitus
- What is being tested?
- Chinese herb medicine
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2021to 15 May 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited Department of Endocrinology, Guang'anmen Hospital, from January 2015 to December 2020.
Who may be able to join
- Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension;
- Received 6 months of continuous Chinese herbal medicine treatment;
- During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
- During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
- Aged 18 to 80 years at the time of their consent;
- Signed informed consent.
Who cannot join
- Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.
Read the detailed description
The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).
- Being tested
- Chinese herb medicine
- Keywords
- type 2 diabetes mellitus, dyslipidemias, obesity, Chinese herbal medicine, retrospective review
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herb medicineDrug
Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Not described Receives: Drug: Chinese herb medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HbA1c at 3 months, 6 months
Measured: 0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months
Measured: 0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months
Measured: 0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months
Measured: 0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months
Measured: 0 month, 3 months, 6 months
Secondary outcomes (5)
Changes from Postprandial Blood Glucose at 6 months
Measured: 0 month, 6 months
Changes from Total Cholesterol at 6 months
Measured: 0 month, 6 months
Changes from High Density Lipoprotein at 6 months
Measured: 0 month, 6 months
Changes from Systolic Blood Pressure at 6 months
Measured: 0 month, 6 months
Changes from Diastolic Blood Pressure at 6 months
Measured: 0 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start27 Oct 2021
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiaxing Tian, PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072990
- Sponsor's protocol ID
- 2020-035-KY
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2021
- Last updated
- 15 Sep 2023
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05072990
- Acronym / sponsor ID
- 2020-035-KY
- Keywords
- type 2 diabetes mellitus, dyslipidemias, obesity, Chinese herbal medicine, retrospective review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 11 Oct 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.
This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.
Detailed description
The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Drug: Chinese herb medicine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited Department of Endocrinology, Guang'anmen Hospital, from January 2015 to December 2020.
Key inclusion criteria (6 listed)
- Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension;
- Received 6 months of continuous Chinese herbal medicine treatment;
- During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
- During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
- Aged 18 to 80 years at the time of their consent;
Key exclusion criteria (1 listed)
- Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.
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 |
|---|---|---|
| Chinese herb medicinePatients took 200 ml Chinese herb decoction twice a day before breakfast and dinner. | Drug | Observational group |
Primary outcome
Change from Baseline HbA1c at 3 months, 6 months
Time frame: 0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months
Time frame: 0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months
Time frame: 0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months
Time frame: 0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months
Time frame: 0 month, 3 months, 6 months
5 secondary outcomes
Changes from Postprandial Blood Glucose at 6 months
Time frame: 0 month, 6 months
Changes from Total Cholesterol at 6 months
Time frame: 0 month, 6 months
Changes from High Density Lipoprotein at 6 months
Time frame: 0 month, 6 months
Changes from Systolic Blood Pressure at 6 months
Time frame: 0 month, 6 months
Changes from Diastolic Blood Pressure at 6 months
Time frame: 0 month, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- 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.
Jiaxing Tian, PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus in Obese and Dyslipidemia Associated With Type II Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HbA1c at 3 months, 6 months (time frame: 0 month, 3 months, 6 months). The study lists 5 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 15 Sep 2023.