Study of Human Adipose Tissue (LOSHAT)

NCT03675464 | Unknown

• 1 other identifier: 2018/809-31
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Change, Body; Weight Loss; Weight Gain; Lipolysis; Adipose Tissue; Human; Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Genetic variations linked to lipolysis

  2018 to 2022

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women previously examined at our laboratory

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Body Weight Changes; Weight Loss; Weight Gain; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter Arner, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Daniel P Andersson, MD, PhD

  Karolinska University Hospital

  STUDY DIRECTOR

• Mikael Rydén, Md, PhD

  Karolinska University Hospital

  STUDY CHAIR

Central Study Contacts

Peter Arner, MD, PhD

CONTACT

+468 58582342; peter.arner@ki.se

Daniel P Andersson, MD, PhD

CONTACT

+468 58580000; daniel.p.andersson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 18, 2018
• Study Start: September 20, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

SE (1)