NCT05475587

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

July 21, 2022

Last Update Submit

July 24, 2022

Conditions

Keywords

prediabetestraditional Chinese medicinebody constitution

Outcome Measures

Primary Outcomes (1)

  • Body constitution of body constitution questionnaire (BCQ)

    The scale range from 44 to 220, with higher scores indicating larger deficiencies.

    One year

Study Arms (2)

Prediabetes cases

Other: Routine care

Healthy controls

Other: Routine care

Interventions

Both two groups received the same routine care.

Healthy controlsPrediabetes cases

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 27, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations