Type2 DiabetesNCT03259321
Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes
An observational study of Type2 Diabetes, run by Zhejiang University.
Trial summary
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2 diabetes (T2D) is heavily debated but evidence from large populations in China is scant. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- How many people
- 15,100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1989to 31 Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities, which take up about half of Chinese population.
Who may be able to join
- Adults aged ≥20 with complete data on diet and follow-up time
Who cannot join
- Missing information for Type 2 diabetes
- Type 2 diabetes
- Cardiovascular disease
About this study
Official title: Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes in CHNS
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2 diabetes (T2D) is heavily debated but evidence from large populations in China is scant. The investigators aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term association between fish, PUFA intake and T2D risk.
Read the detailed description
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is heavily debated but evidence from large populations in China is still lacking. The investigators aim to utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). The investigators will calculate cumulative means of fish and PUFA intake based on 3-day food records in each wave. Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results from this work will provide epidemiological evidence for improving recommendations on fish and PUFA intake for Chinese in dietary guidelines.
- Conditions
- Type2 Diabetes
- Keywords
- Fish, Polyunsaturated fatty acids, CHNS
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes
Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
Measured: From entry into the study (baseline: 1997-2009) until 2011
Secondary outcomes (1)
Fish and polyunsaturated fatty acids intake
Cumulative averages of fish and PUFA intake based on 3-day 24-hr recall in each wave
Measured: From entry into the study (baseline: 1997-2009) until 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jan 1989
- Primary completion31 Dec 2011
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Responsible party
- Principal investigator, Jingjing Jiao, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259321
- Sponsor's protocol ID
- Cohort_PUFA_T2D
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhuang P, Mao L, Wu F, Wang J, Jiao J, Zhang Y. Cooking Oil Consumption Is Positively Associated with Risk of Type 2 Diabetes in a Chinese Nationwide Cohort Study. J Nutr. 2020 Jul 1;150(7):1799-1807. doi: 10.1093/jn/nxaa103.
PubMed 32364230Wu F, Mao L, Zhuang P, Chen X, Jiao J, Zhang Y. Plant-sourced cooking oil consumption is associated with lower total mortality in a longitudinal nationwide cohort study. Clin Nutr. 2020 Dec;39(12):3703-3710. doi: 10.1016/j.clnu.2020.03.031. Epub 2020 Apr 2.
PubMed 32359931Zhuang P, Shou Q, Wang W, He L, Wang J, Chen J, Zhang Y, Jiao J. Essential Fatty Acids Linoleic Acid and alpha-Linolenic Acid Sex-Dependently Regulate Glucose Homeostasis in Obesity. Mol Nutr Food Res. 2018 Sep;62(17):e1800448. doi: 10.1002/mnfr.201800448. Epub 2018 Aug 12.
PubMed 29935107
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes in CHNS
- ClinicalTrials.gov ID
- NCT03259321
- Acronym / sponsor ID
- Cohort_PUFA_T2D
- Conditions
- Type2 Diabetes
- Keywords
- Fish, Polyunsaturated fatty acids, CHNS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,100 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Study start
- 1 Jan 1989 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 23 Aug 2017 (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.
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2 diabetes (T2D) is heavily debated but evidence from large populations in China is scant. The investigators aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term association between fish, PUFA intake and T2D risk.
Detailed description
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is heavily debated but evidence from large populations in China is still lacking. The investigators aim to utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). The investigators will calculate cumulative means of fish and PUFA intake based on 3-day food records in each wave. Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results from this work will provide epidemiological evidence for improving recommendations on fish and PUFA intake for Chinese in dietary guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities, which take up about half of Chinese population.
Key inclusion criteria (1 listed)
- Adults aged ≥20 with complete data on diet and follow-up time
Key exclusion criteria (3 listed)
- Missing information for Type 2 diabetes
- Type 2 diabetes
- Cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type 2 diabetes
Time frame: From entry into the study (baseline: 1997-2009) until 2011
Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
1 secondary outcome
Fish and polyunsaturated fatty acids intake
Time frame: From entry into the study (baseline: 1997-2009) until 2011
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 Mar 2024.
- Derived from this study: PubMed 32364230Zhuang P, Mao L, Wu F, Wang J, Jiao J, Zhang Y. Cooking Oil Consumption Is Positively Associated with Risk of Type 2 Diabetes in a Chinese Nationwide Cohort Study. J Nutr. 2020 Jul 1;150(7):1799-1807. doi: 10.1093/jn/nxaa103.
- Derived from this study: PubMed 32359931Wu F, Mao L, Zhuang P, Chen X, Jiao J, Zhang Y. Plant-sourced cooking oil consumption is associated with lower total mortality in a longitudinal nationwide cohort study. Clin Nutr. 2020 Dec;39(12):3703-3710. doi: 10.1016/j.clnu.2020.03.031. Epub 2020 Apr 2.
- Derived from this study: PubMed 29935107Zhuang P, Shou Q, Wang W, He L, Wang J, Chen J, Zhang Y, Jiao J. Essential Fatty Acids Linoleic Acid and alpha-Linolenic Acid Sex-Dependently Regulate Glucose Homeostasis in Obesity. Mol Nutr Food Res. 2018 Sep;62(17):e1800448. doi: 10.1002/mnfr.201800448. Epub 2018 Aug 12.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Zhejiang University.
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 1 inclusion and 3 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Type 2 diabetes (time frame: From entry into the study (baseline: 1997-2009) until 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259321, which also lists 3 linked publications.
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 Mar 2024.