- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475587
The Association Between Body Constitution and Meridian Energy in Prediabetes
The Association Between Body Constitution and Meridian Energy Among Individuals With Prediabetes
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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New Taipei City, Taiwan, 231
- Taipei Tzu Chi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy controls
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Both two groups received the same routine care.
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Prediabetes cases
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Both two groups received the same routine care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body constitution of body constitution questionnaire (BCQ)
Time Frame: One year
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The scale range from 44 to 220, with higher scores indicating larger deficiencies.
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One year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-XD-082
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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