Hydroxymethylation, Incident Type 2 Diabetes and Incident Obesity
1 other identifier
observational
126
1 country
1
Brief Summary
The proposed discordant identical and fraternal twin study of incident type 2 diabetes and incident obesity is pivotal to public health because this study design compares diseased twins with their non-diseased co-twins for a better understanding of environment-induced hydroxymethylation independent of genetic influences as the novel biological mechanism underlying the diseases. By engaging students in the proposed co-twin control study, we will prepare our next generation of public health researchers to sustain our impact on public health across generations. The discovery of new environmentally and epigenetically therapeutic and preventive regimens will pave the way to fight against incident type 2 diabetes and incident obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMarch 15, 2023
March 1, 2023
3 years
March 3, 2023
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
novel differentially hydroxymethylated regions (DhMRs) concerning incident type 2 diabetes
Whole-genome 5hmC will be measured among MZ and DZ twin pairs discordant for incident type 2 diabetes
April 1, 2023 to December 31, 2023
novel DhMRs concerning incident obesity
Whole-genome 5hmC will be measured among MZ and DZ twin pairs discordant for incident obesity
April 1, 2023 to December 31, 2023
evidence-based DhMRs concerning incident type 2 diabetes
literature review will be performed to find the candidate DhMRs
May1, 2022 to December 31, 2023
evidence-based DhMRs concerning incident obesity
literature review will be performed to find the candidate DhMRs
May1, 2022 to December 31, 2023
Study Arms (2)
NTS iT2D-dTwin case-co-twin-control cohort
The twin pairs discordant for incident type 2 diabetes (iT2D) \[17 monozygotic (MZ) and 20 dizygotic twin pairs (DZ)\] are included from the National Heart, Lung, and Blood Institute (NHLBI) Twin Study (NTS). In a discordant twin pair, one co-twin developed iT2D while his co-twin did not or develop iT2D at least one year later.
NTS iOB-dTwin case-co-twin-control cohort
The twin pairs discordant for incident obesity (iOB) \[11 monozygotic (MZ) and 15 dizygotic twin pairs (DZ)\] are included from the National Heart, Lung, and Blood Institute (NHLBI) Twin Study (NTS). In a discordant twin pair, one co-twin developed iOB while his co-twin did not or develop iOB at least one year later.
Interventions
This study is an observational study only.
Eligibility Criteria
Below is the Parent Cohort Description: The NHLBI Twin Study (NTS) is a prospective study of the genetic and environmental etiology of cardiovascular disease. Initiated in 1969, researchers recruited 514 white male twin pairs (i.e., 1,024 men) born between 1917 and 1927. The twins were roughly 50% monozygotic twin pairs (MZ) and 50% dizygotic twin pairs (DZ) and were middle-aged at baseline (1969-1973). The five research sites were Framingham, MA; San Francisco, CA; Davis, CA; Los Angeles, CA; and Indianapolis, IN. The participant inclusion criterion was the geographic proximity to the study sites (within 100 miles in New England and California, and within 200 miles of Indianapolis, Indiana). The twins received physical examinations based on the renowned Framingham Heart Study protocol.
You may qualify if:
- In the NHLBI Twin Study, middle-aged, male, veteran twins were recruited at baseline (1969-1973).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Des Moines Universitylead
- Indiana Universitycollaborator
- Penn State Universitycollaborator
- EpiGenTek, LLCcollaborator
Study Sites (1)
Des Moines University
Des Moines, Iowa, 50312, United States
Biospecimen
Buffy coat DNA samples were collected in the mid-1980. This study used the discordant twin design, a specific nested case-co-twin control design.
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Dai, MD, PhD
Des Moines University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
March 1, 2021
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
Data Sharing Plan: All investigators will adhere to the NIH policies for data sharing. De-identified data will be available and shared commonly 6 months after the investigators' quality manuscript is accepted. The data sharing agreement will be required. We will also share data through presentations at scientific meetings, research seminars, and publications of manuscripts. Genomic Data Sharing Plan (GDS) This application generates whole genome hydroxymethylation using the enrichment-based method followed by NextGen-seq. These data will be shared with investigators who prepare a manuscript.