PrediabetesNCT05475587
The Association Between Body Constitution and Meridian Energy in Prediabetes
An observational study of Prediabetes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy are the foundations for disease prevention. However, few studies have incorporated TCM concepts into risk factors. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Routine care
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The researchers included 30 adults with prediabetes and 30 healthy controls, matched for age and sex, recruited from the outpatient clinic and health examination center at a teaching hospital in northern Taiwan.
Who may be able to join
- Previously diagnosed prediabetes with a hemoglobin A1c (HbA1c) of 5.7-6.4% and a f asting plasma glucose (FPG) of 100-125 mg/dL
- Aged ≥20
- provided informed consent
- The controls were healthy individuals whose FPG level was 100 mg/dL in at least two blood tests in the past 6 months.
Who cannot join
- Use of a hypoglycemic agent within the past 3 months
- Self-reported catastrophic illness in the last 6 months
- Pregnant and/or lactating
- Presence of pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Body Constitution and Meridian Energy Among Individuals With Prediabetes
Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy are the foundations for disease prevention. However, few studies have incorporated TCM concepts into risk factors. This study aimed to examine the association between body constitution and meridian energy in individuals with prediabetes. We conducted a matched case-control study that included 60 individuals with prediabetes. Finally, the reseachers have found that body constitution may be a risk factor fpr progression to type 2 diabetes mellitus in individuals with prediabetes.
Read the detailed description
Objective: Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy are the foundations for disease prevention. However, few studies have incorporated TCM concepts into risk factors. This study aimed to examine the association between body constitution and meridian energy in patients with prediabetes.
Methods: The researchers conducted a matched case-control study from January to December 2019 that included 30 adults with prediabetes and 30 healthy controls, matched for age and sex, recruited from the outpatient clinic and health examination center at a teaching hospital in northern Taiwan. Body constitution was measured using the Body Constitution Questionnaire, which classifies the constitution as yang-deficiency, ying-deficiency, and phlegm-stasis, while meridian energy was measured using an Aetoscan meridian energy device (Aeto Technology Co. Ltd., Taiwan). The associations between body constitution, meridian energy, and prediabetes were examined using binary logistic regression analyses.
Conclusion: Body constitution may be a risk factor for progression to type 2 diabetes mellitus in patients with prediabetes and warrants further study.
- Conditions
- Prediabetes
- Being tested
- Routine care
- Keywords
- prediabetes, traditional Chinese medicine, body constitution
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Both two groups received the same routine care.
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes cases | Not described Receives: Other: Routine care | |
| Healthy controls | Not described Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body constitution of body constitution questionnaire (BCQ)
The scale range from 44 to 220, with higher scores indicating larger deficiencies.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475587
- Sponsor's protocol ID
- 07-XD-082
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Body Constitution and Meridian Energy Among Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT05475587
- Acronym / sponsor ID
- 07-XD-082
- Conditions
- Prediabetes
- Keywords
- prediabetes, traditional Chinese medicine, body constitution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Jul 2022 (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.
Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy are the foundations for disease prevention. However, few studies have incorporated TCM concepts into risk factors. This study aimed to examine the association between body constitution and meridian energy in individuals with prediabetes. We conducted a matched case-control study that included 60 individuals with prediabetes. Finally, the reseachers have found that body constitution may be a risk factor fpr progression to type 2 diabetes mellitus in individuals with prediabetes.
Detailed description
Objective: Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy are the foundations for disease prevention. However, few studies have incorporated TCM concepts into risk factors. This study aimed to examine the association between body constitution and meridian energy in patients with prediabetes.
Methods: The researchers conducted a matched case-control study from January to December 2019 that included 30 adults with prediabetes and 30 healthy controls, matched for age and sex, recruited from the outpatient clinic and health examination center at a teaching hospital in northern Taiwan. Body constitution was measured using the Body Constitution Questionnaire, which classifies the constitution as yang-deficiency, ying-deficiency, and phlegm-stasis, while meridian energy was measured using an Aetoscan meridian energy device (Aeto Technology Co. Ltd., Taiwan). The associations between body constitution, meridian energy, and prediabetes were examined using binary logistic regression analyses.
Conclusion: Body constitution may be a risk factor for progression to type 2 diabetes mellitus in patients with prediabetes and warrants further study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetes cases | – | Other: Routine care |
| Healthy controls | – | Other: Routine care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The researchers included 30 adults with prediabetes and 30 healthy controls, matched for age and sex, recruited from the outpatient clinic and health examination center at a teaching hospital in northern Taiwan.
Key inclusion criteria (4 listed)
- Previously diagnosed prediabetes with a hemoglobin A1c (HbA1c) of 5.7-6.4% and a f asting plasma glucose (FPG) of 100-125 mg/dL
- Aged ≥20
- provided informed consent
- The controls were healthy individuals whose FPG level was 100 mg/dL in at least two blood tests in the past 6 months.
Key exclusion criteria (4 listed)
- Use of a hypoglycemic agent within the past 3 months
- Self-reported catastrophic illness in the last 6 months
- Pregnant and/or lactating
- Presence of pacemaker.
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 |
|---|---|---|
| Routine careBoth two groups received the same routine care. | Other | Healthy controls, Prediabetes cases |
Primary outcome
Body constitution of body constitution questionnaire (BCQ)
Time frame: One year
The scale range from 44 to 220, with higher scores indicating larger deficiencies.
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 27 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prediabetes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 4 inclusion and 4 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 27 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 Taiwan. 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?
Body constitution of body constitution questionnaire (BCQ) (time frame: One year). 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 27 Jul 2022.