Clinical trial NCT03675464: Study of Human Adipose Tissue (LOSHAT)
Official title: Longitudinal Observational Study of Human Adipose Tissue (LOSHAT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Change, Body
Weight Loss
Weight Gain
Lipolysis
Adipose Tissue
Human
Obesity
Type 2 Diabetes Mellitus
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2018-09-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women previously examined at our laboratory

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body mass index
timeFrame: 2018 to 2022
measure: Fasting glucose
timeFrame: 2018 to 2022
measure: Number of participants with metabolic syndrome
timeFrame: 2018 to 2022
measure: Number of participants with type 2 Diabetes
timeFrame: 2018 to 2022
measure: Number of participants with dyslipidemia
timeFrame: 2018 to 2022
measure: Number of participants with Hypertension
timeFrame: 2018 to 2022
Secondary outcomes:
measure: Genetic variations linked to lipolysis
timeFrame: 2018 to 2022
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Peter Arner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Daniel P Andersson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska University Hospital
name: Mikael Rydén, Md, PhD
role: STUDY_CHAIR
References: