Tzu Chi Health Study (Diabetes and Cardiometabolic Health Components)

NCT03204552 | Completed

• 1 other identifier: TCHS-01
• Study Type: observational
• Target: 6,002
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of diet and lifestyle, particularly vegetarian diets on chronic degenerative disease outcomes in a cohort of Taiwanese Buddhists participants

Conditions

Diabetes; Fatty Liver; Cardiometabolic Health; Body Mass Index

Outcome Measures

Primary Outcomes (4)

• Diabetes

  Diabetes incidence as determined through biochemical markers (fasting blood sugar, HbA1C), disease follow-up questionnaire, and medical records

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years

• Fatty liver

  Fatty liver incidence as assessed through ultrasonography, disease follow-up questionnaire, and medical records

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years

• Change in cardiometabolic health markers

  plasma lipids (cholesterol, triglyceride), pulse wave velocity, blood pressures; these markers may be combined to calculate metabolic syndrome or other scores representing metabolic health

  The above outcomes would be measured at baseline, 3rd year, and 6th year

• Change in BMI

  Change in BMI (calculated through height and weigh)

  The above outcomes would be measured at baseline, 3rd year, and 6th year

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

More than 70% of the participants are Tzu Chi Commissioners. The female-to-male ratio is about 2:1, and about one-third of study participants were vegetarians.

You may qualify if:

• Adult individuals who came to Dalin Tzu Chi Hospital for health examination between 2007 to 2009.
• Willing to participate in the study, be interviewed on questionnaires on demographics, diet, and lifestyle; willing to release health examination data for study purpose, and willing to be followed-up on health outcome

You may not qualify if:

• Participants less than 18 years old.

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi Hospital

Chiayi City, Taiwan

Location

Related Publications (4)

• Chiu TH, Huang HY, Chen KJ, Wu YR, Chiu JP, Li YH, Chiu BC, Lin CL, Lin MN. Relative validity and reproducibility of a quantitative FFQ for assessing nutrient intakes of vegetarians in Taiwan. Public Health Nutr. 2014 Jul;17(7):1459-66. doi: 10.1017/S1368980013001560. Epub 2013 Jun 20.

  PMID: 23782894 BACKGROUND

• Chiu TH, Huang HY, Chiu YF, Pan WH, Kao HY, Chiu JP, Lin MN, Lin CL. Taiwanese vegetarians and omnivores: dietary composition, prevalence of diabetes and IFG. PLoS One. 2014 Feb 11;9(2):e88547. doi: 10.1371/journal.pone.0088547. eCollection 2014.

  PMID: 24523914 RESULT

• Chiu THT, Pan WH, Lin MN, Lin CL. Vegetarian diet, change in dietary patterns, and diabetes risk: a prospective study. Nutr Diabetes. 2018 Mar 9;8(1):12. doi: 10.1038/s41387-018-0022-4.

  PMID: 29549240 RESULT

• Chiu TH, Lin MN, Pan WH, Chen YC, Lin CL. Vegetarian diet, food substitution, and nonalcoholic fatty liver. Tzu Chi Med J. 2018 Apr-Jun;30(2):102-109. doi: 10.4103/tcmj.tcmj_109_17.

  PMID: 29875591 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Fatty Liver

Interventions

Observation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Chin-Lon Lin, MD

  Tzu Chi Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: July 2, 2017
• Study Start: October 15, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

TW (1)