Skeletal Maturation and Endocrine Health in Young Adults
NCT Number: NCT06509776
Acronym: EPIPEAK
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoporosis|Sarcopenia|Obesity|Cardiovascular Diseases
Sponsor: Holbaek Sygehus
Collaborators: Aarhus University Hospital|Aalborg University Hospital|University of Southern Denmark|University Hospital Bispebjerg and Frederiksberg|Zealand University Hospital|Hvidovre University Hospital|Odense University Hospital|Statens Serum Institut|Rigshospitalet, Denmark
Sex: ALL
Age: ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2031-09
Locations: Aalborg University Hospital, Department of Endocrinology, Aalborg, 9000, Denmark|Aarhus University Hospital, Department of Endocrinology, Aarhus, 8200, Denmark|Rigshospitalet, Department of Clinical Biochemistry and Endocrinology, Copenhagen, 2200, Denmark|Bispebjerg and Frederiksberg Hospital, EEK, Parker Institute, Frederiksberg, 2000, Denmark|Holbæk Hospital, Department of Medicine, Holbæk, 4300, Denmark|Hvidovre Hospital, Department of Endocrinology, Hvidovre, 2650, Denmark|Zealand University Hospital, Department of Medicine, Køge, 4600, Denmark|Odense University Hospital, Department of Endocrinology, Odense, 5000, Denmark|University of Southern Denmark, Department of Clinical Research, Odense, 5000, Denmark

Summary:
Diseases which can be the result of poor lifestyle choices in adult life, such as osteoporosis, obesity or poor muscle mass (sarcopenia) can also be driven by heritable genetic factors. More surprisingly, perhaps, the genes we inherit from our parents can be modified as a result of influences that affected the health and pregnancy of our mothers and hence the environment experienced in the womb and at birth. The purpose of this study is to investigate which factors are needed for good bone health and hormonal health in young adulthood as well as good muscle mass and normal fat mass, and how this is influenced by factors before birth and by childhood health. Specifically, we will measure bone mass and body composition in young adults (18 years of age) and measure hormones in blood and in hair samples. The clinical visits will be available nationwide at several centers to make participation swift and easy for participants. The changes (known as epigenetic modification) to genes at birth will be studied in dried blood spot samples stored from birth 18 years ago in the Danish Serum Institute and we will use national health registers to identify factors during pregnancy and in childhood that contribute to health effects at age 18.

Primary Outcome Measures: Bone Mineral Density of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral density (BMD) of the spine, hip and whole-body., Baseline|Bone Mineral Density of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral density (BMD) of the spine, hip and whole-body., 2 years|Bone Area of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone area (BA) of the spine, hip and whole-body., Baseline|Bone Area of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone area (BA) of the spine, hip and whole-body., 2 years|Bone Mineral Content of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral content (BMC) in the spine, hip and whole-body., Baseline|Bone Mineral Content of Spine, Hip and Whole-body, The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral content (BMC) in the spine, hip and whole-body., 2 years
Secondary Outcome Measures: Total Body Lean Mass, The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body lean mass in kg., Baseline|Total Body Lean Mass, The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body lean mass in kg., 2 years|Total Body Fat Mass, The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body fat mass in kg., Baseline|Total Body Fat Mass, The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body fat mass in kg., 2 years|High-Resolution Peripheral Quantitative Computed Tomography of The Distal Radius and Tibia, High-resolution peripheral quantitative computed tomography (HRpQCT) of the distal radius and tibia will provide structural information including cortical thickness, trabecular number, trabecular thickness and volumetric bone mineral density (vBMD), Baseline|High-Resolution Peripheral Quantitative Computed Tomography of The Distal Radius and Tibia, High-resolution peripheral quantitative computed tomography (HRpQCT) of the distal radius and tibia will provide structural information including cortical thickness, trabecular number, trabecular thickness and volumetric bone mineral density (vBMD), 2 years|Body Weight, Weight will be measured to the nearest 0.1 kg on an electronic scale with participants wearing light clothing. Measurement will be carried out barefoot., Baseline|Body Weight, Weight will be measured to the nearest 0.1 kg on an electronic scale with participants wearing light clothing. Measurement will be carried out barefoot., 2 years|Height, Height will be measured to the nearest 0.5 cm using a portable stadiometer. Measurement will be carried out barefoot, Baseline|Height, Height will be measured to the nearest 0.5 cm using a portable stadiometer. Measurement will be carried out barefoot, 2 years|Body Mass Index, Body Mass Index (BMI) will be calculated based on the participant's weight and height, Baseline|Body Mass Index, Body Mass Index (BMI) will be calculated based on the participant's weight and height, 2 years|Waist Circumference, The waist circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm, Baseline|Waist Circumference, The waist circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm, 2 years|Hip Circumference, The hip circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm, Baseline|Hip Circumference, The hip circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm, 2 years|Waist-Hip Ratio, The waist-hip ratio is calculated using the waist and hip circumference, Baseline|Waist-Hip Ratio, The waist-hip ratio is calculated using the waist and hip circumference, 2 years|Endocrine Status, Blood will be drawn for plasma analyses for endocrine status, Baseline|Endocrine Status and Bone Markers of Bone Metabolism, Blood will be drawn for plasma analyses for endocrine status and biomarkers of bone metabolism (PINP and CTX), Baseline|Hair Cortisol Concentrations, The hair samples will be cut from the posterior apex as close to the scalp as possible (minimum 20 mg per participant). Cortisol extracted from the hair will be analysed via the Elisa method, Baseline|Blood Pressure, Resting blood pressure will be measured, Baseline|Blood Pressure, Resting blood pressure will be measured, 2 years
Other Outcome Measures: Self-reported Stress, Information about well-being will be collected by electronic questionnaire, using the World Health Organization Well-Being index (WHO-5): (1) 'I have felt cheerful and in good spirits', (2) 'I have felt calm and relaxed', (3) 'I have felt active and vigorous', (4) 'I woke up feeling fresh and rested' and (5) 'My daily life has been filled with things that interest me'. The respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). Score ranges from 0 (absence of well-being) to 25 (maximal well-being)., Baseline|Self-reported Sleep, Information about sleep will be collected by electronic questionnaire. The respondent is asked about what time he or she goes to sleep and wakes up on the weekdays and weekends/holidays, as well as five elaborating questions about their sleeping pattern: (1) 'How often do you have poor or restless sleep?', (2) 'How often do you have trouble falling asleep?', (3) 'How often do you wake up too early in the morning?', (4) 'How often do you wake up multiple times at night and have trouble falling asleep again?' and (5) 'Do you snore loudly when you sleep?'. Each of the 5 items is scored from 4 (every day or almost every day) to 1 (rarely or never)., Baseline|Self-reported Hearing, Information about tinnitus will be collected by electronic questionnaire. The respondent is asked the following five questions: (1) 'After listening to loud music or other sounds/noise, have you then heard any form of sounds in your head or ears, even after turning off the loud music or noise?', (2) 'Do you ever experience sounds in your head or ears without listening to loud music or other sounds first?', (3) 'Are you experiencing it today?', (4) 'Does the sound bother you?' and (5) 'How worried are you that sound can harm your hearing?'. The questions 1 to 3 are answered as yes or no. Question 4 is answered as not bothered; a little bothered or very bothered. Question 5 is I am not concerned; I am a little concerned or I am seriously concerned., Baseline