Study of Human Adipose Tissue (LOSHAT) (LOSHAT)

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Type 2 Diabetes Mellitus; Weight Loss; Weight Gain; Weight Change, Body; Adipose Tissue; Human; Lipolysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Peter Arner, MD, PhD; Phone Number: +468 58582342; Email: peter.arner@ki.se
• Study Contact Backup: Name: Daniel P Andersson, MD, PhD; Phone Number: +468 58580000; Email: daniel.p.andersson@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Recruiting
    • Karolinska University Hospital
    • Contact: Daniel P Andersson, MD, PhD; Email: daniel.p.andersson@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women previously examined at our laboratory

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Peter Arner, MD, PhD, Karolinska University Hospital; Study Director: Daniel P Andersson, MD, PhD, Karolinska University Hospital; Study Chair: Mikael Rydén, Md, PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Loss; Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: 2018/809-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No