Obesity Clinical Trial
— LOSHATOfficial title:
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).
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index | 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. | 2018 to 2022 | |
Primary | Fasting glucose | 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). | 2018 to 2022 | |
Primary | Number of participants with metabolic syndrome | 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. | 2018 to 2022 | |
Primary | Number of participants with type 2 Diabetes | 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. | 2018 to 2022 | |
Primary | Number of participants with dyslipidemia | 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. | 2018 to 2022 | |
Primary | Number of participants with Hypertension | 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. | 2018 to 2022 | |
Secondary | Genetic variations linked to lipolysis | 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. | 2018 to 2022 |
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