Weight Change, BodyLOSHATNCT03675464
Study of Human Adipose Tissue (LOSHAT)
An observational study of Weight Change, Body and Weight Loss, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Change, Body, Weight Loss, Weight Gain
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 20 Sep 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women previously examined at our laboratory
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Daniel P Andersson, MD, PhD, daniel.p.andersson@ki.se
About this study
Official 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).
Read the 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.
- Conditions
- Weight Change, Body, Weight Loss, Weight Gain, Lipolysis, Adipose Tissue, Human
- Medical subject headings
- Body Weight Changes, Weight Loss, Weight Gain, Obesity, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2018 to 2022
Secondary outcomes (1)
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.
Measured: 2018 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start20 Sep 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Peter Arner, Karolinska University Hospital
- Investigators
- Peter Arner, MD, PhD, Principal investigator, Karolinska University HospitalDaniel P Andersson, MD, PhD, Study director, Karolinska University HospitalMikael Rydén, Md, PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675464
- Sponsor's protocol ID
- 2018/809-31
- Acronym
- LOSHAT
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study of Human Adipose Tissue (LOSHAT)
- ClinicalTrials.gov ID
- NCT03675464
- Acronym / sponsor ID
- LOSHAT / 2018/809-31
- Conditions
- Weight Change, Body, Weight Loss, Weight Gain, Lipolysis, Adipose Tissue, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women previously examined at our laboratory
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index
Time frame: 2018 to 2022
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.
Fasting glucose
Time frame: 2018 to 2022
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).
Number of participants with metabolic syndrome
Time frame: 2018 to 2022
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.
Number of participants with type 2 Diabetes
Time frame: 2018 to 2022
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.
Number of participants with dyslipidemia
Time frame: 2018 to 2022
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.
Number of participants with Hypertension
Time frame: 2018 to 2022
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.
1 secondary outcome
Genetic variations linked to lipolysis
Time frame: 2018 to 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Arner, MD, PhD principal investigator
Karolinska University Hospital
Daniel P Andersson, MD, PhD study director
Karolinska University Hospital
Mikael Rydén, Md, PhD study chair
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Change, Body and Weight Loss, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Arner, MD, PhD (+468 58582342, peter.arner@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 2018 to 2022). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.