Study of Human Adipose Tissue (LOSHAT) (LOSHAT)
2 september 2020 uppdaterad 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).
Studieöversikt
Status
Rekrytering
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
1500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Peter Arner, MD, PhD
- Telefonnummer: +468 58582342
- E-post: peter.arner@ki.se
Studera Kontakt Backup
- Namn: Daniel P Andersson, MD, PhD
- Telefonnummer: +468 58580000
- E-post: daniel.p.andersson@ki.se
Studieorter
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Stockholm, Sverige, 14186
- Rekrytering
- Karolinska University Hospital
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Kontakt:
- Daniel P Andersson, MD, PhD
- E-post: daniel.p.andersson@ki.se
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Men and women previously examined at our laboratory
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Body mass index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Genetic variations linked to lipolysis
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Peter Arner, MD, PhD, Karolinska University Hospital
- Studierektor: Daniel P Andersson, MD, PhD, Karolinska University Hospital
- Studiestol: Mikael Rydén, Md, PhD, Karolinska University Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 september 2018
Primärt slutförande (Förväntat)
31 december 2022
Avslutad studie (Förväntat)
31 december 2023
Studieregistreringsdatum
Först inskickad
23 augusti 2018
Först inskickad som uppfyllde QC-kriterierna
14 september 2018
Första postat (Faktisk)
18 september 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018/809-31
Läkemedels- och apparatinformation, studiedokument
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Nej
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