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To understand causes, trajectories and patterns of early and overt cardiometabolic disease manifestations, we will perform a combined clinical deep phenotyping and registry follow-up study of the now 50\u201380 years old Inter99 participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The Inter99 cohort comprises individuals aged 30\u201360 years, who lived in a representative geographical area of greater Copenhagen, Denmark, in 1999. Age-stratified and sex-stratified random subgroups were invited to participate in either a lifestyle intervention (N=13\u2009016) or questionnaires (N=5264), while the rest served as a reference population (N=43\u2009021). Of the 13\u2009016 individuals assigned to the lifestyle intervention group, 6784 (52%) accepted participation in a baseline health examination in 1999, including screening for cardiovascular risk factors and prediabetic conditions. In total, 6004 eligible participants, who participated in the baseline examination, will be invited to participate in the deep phenotyping 20-year follow-up clinical examination including measurements of anthropometry, blood pressure, arterial stiffness, cardiometabolic biomarkers, coronary artery calcification, heart rate variability, heart rhythm, liver stiffness, fundus characteristics, muscle strength and mass, as well as health and lifestyle questionnaires. In a subsample, 10-day monitoring of diet, physical activity and continuous glucose measurements will be performed. Fasting blood, urine and faecal samples to be stored in a biobank. The established database will form the basis of multiple analyses. A main purpose is to investigate whether low birth weight independent of genetics, lifestyle and glucose tolerance predicts later common T2D cardiometabolic comorbidities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by the Medical Ethics Committee, Capital Region, Denmark (H-20076231) and by the Danish Data Protection Agency through the Capital Region of Denmark\u2019s registration system (P-2020-1074). Informed consent will be obtained before examinations. Findings will be disseminated in peer-reviewed journals, at conferences and via presentations to stakeholders, including patients and public health policymakers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05166447\">NCT05166447<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-078501","type":"journal-article","created":{"date-parts":[[2024,1,29]],"date-time":"2024-01-29T22:17:15Z","timestamp":1706566635000},"page":"e078501","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Protocol for the combined cardiometabolic deep phenotyping and registry-based 20-year follow-up study of the Inter99 cohort"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05166447","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05166447","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05259046","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Kirsten Schroll","family":"Bj\u00f8rnsbo","sequence":"first","affiliation":[{"name":"Center for Clinical Research and Prevention, Copenhagen University Hospital \u2013 Bispebjerg and Frederiksberg, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6653-9020","authenticated-orcid":false,"given":"Charlotte","family":"Br\u00f8ns","sequence":"additional","affiliation":[{"name":"Steno Diabetes Center Copenhagen, Herlev, 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