Study of Human Adipose Tissue (LOSHAT) (LOSHAT)
2. september 2020 oppdatert av: Peter Arner, Karolinska University Hospital
Longitudinal Observational Study of Human Adipose Tissue (LOSHAT)
The investigators will study the influence of initial fat cell size/number and adipose function (in particular lipolysis) on weight development over very long time periods (years).
By comparing investigations of fat biopsies or blood samples obtained at baseline, the investigators will determine the association between adipose morphology/function and changes in weight or development of metabolic complications (e.g.
metabolic syndrome, glucose intolerance, type 2 diabetes, dyslipidemia and hypertension).
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
The investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study.
Previously obtained results from examinations of adipose tissue, anthropometric measurements and blood samples will be used as baseline. In addition, saved blood samples and samples from old fat biopsies can be re-investigated in some cases.
The new investigation includes a questionnaire that the subjects can answer by mail or email. In addition, anthropometric measurements and blood pressure determination will be performed at a primary health care center and blood samples will be collected for analysis of fasting glucose, HbA1C and lipids.
Information regarding all previously investigated subjects will also be collected from several Swedish national patient registries such as the Patient Register, Prescribed Drug register and Cause-of Death register.
Studietype
Observasjonsmessig
Registrering (Forventet)
1500
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Peter Arner, MD, PhD
- Telefonnummer: +468 58582342
- E-post: peter.arner@ki.se
Studer Kontakt Backup
- Navn: Daniel P Andersson, MD, PhD
- Telefonnummer: +468 58580000
- E-post: daniel.p.andersson@ki.se
Studiesteder
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Stockholm, Sverige, 14186
- Rekruttering
- Karolinska University Hospital
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Ta kontakt med:
- Daniel P Andersson, MD, PhD
- E-post: daniel.p.andersson@ki.se
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Men and women previously examined at our laboratory
Beskrivelse
Inclusion Criteria:
- Previously participated in examinations at the investigators laboratory and donated adipose tissue.
- Previously participated in examinations at the investigators laboratory and donated blood samples that can be used to estimate lipolysis with a formula.
Exclusion Criteria:
- Decline to participate after invitation.
- Severe Psychiatric disease.
- Type 1 Diabetes
- Participants that have undergone bariatric surgery will be exluded in the primary analysis but will be analyzed separately in a secondary analysis for all above mentioned outcomes.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body mass index
Tidsramme: 2018 to 2022
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Body weight (in kilogram) will be assessed with a regular scale.
Height will be measured with a tape measure (in centimeters).
Body mass index (BMI) will be calculated with the formula weight (kg) divided by height^2 (in meter).
Changes in BMI from baseline values will be analysed.
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2018 to 2022
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Fasting glucose
Tidsramme: 2018 to 2022
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Fasting plasma glucose will be assessed and divided into normal glucose (glucose < 6.1 mmol/L), impaired fasting glucose (glucose 6.1-6.9 mmol/L) or type 2 diabetes (glucose > 6.9 mmol/L).
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2018 to 2022
|
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Number of participants with metabolic syndrome
Tidsramme: 2018 to 2022
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Metabolic syndrome is defined according to International Diabetes Federation, Waist circumference ≥102 cm for men or ≥88 cm for women.
In addition to this 2 of the following; Raised triglycerides: > 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality; Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males, < 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality; Raised blood pressure (BP): systolic BP > 130 or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension; Raised fasting plasma glucose (FPG): >100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
Scores are 0-5.
≥ 3 is defined as metabolic syndrome.
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2018 to 2022
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Number of participants with type 2 Diabetes
Tidsramme: 2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for Type 2 diabetes in the Swedish National Prescribed Drug Register or direct information from the subject.
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2018 to 2022
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Number of participants with dyslipidemia
Tidsramme: 2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for dyslipidemia in the Swedish National Prescribed Drug Register, or direct information from the subject.
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2018 to 2022
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Number of participants with Hypertension
Tidsramme: 2018 to 2022
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Based on a diagnosis in the Swedish National Patient Register, or prescribed drugs for hypertension in the Swedish National Prescribed Drug Register, or direct information from the subject.
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2018 to 2022
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Genetic variations linked to lipolysis
Tidsramme: 2018 to 2022
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Genome-wide association study (GWAS) with focus on genes related to lipolysis and analysis of single nucleotide polymorphisms (SNPs).
Samples from baseline examination will be used in the analysis.
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2018 to 2022
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Peter Arner, MD, PhD, Karolinska University Hospital
- Studieleder: Daniel P Andersson, MD, PhD, Karolinska University Hospital
- Studiestol: Mikael Rydén, Md, PhD, Karolinska University Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. september 2018
Primær fullføring (Forventet)
31. desember 2022
Studiet fullført (Forventet)
31. desember 2023
Datoer for studieregistrering
Først innsendt
23. august 2018
Først innsendt som oppfylte QC-kriteriene
14. september 2018
Først lagt ut (Faktiske)
18. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018/809-31
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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