AzTrials
AzTrials

ObesitySOWOTNCT02227043

Study Of Weight Development Over Time

An observational study of Obesity and Insulin Resistance, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will study the influence of fat cell size/number and adipose function on weight development over very long time periods (years). By comparing fat biopsies obtained at baseline and after >7 years, the investigators will determine the association between adipose morphology/function and changes in… Read more about this study

Who is it for?
Ages 24 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Insulin Resistance, Weight Reduction
How many people
105 participants
Where
1 siteSweden
Study dates
Sep 2014to 1 Mar 2017
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 24 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Observational study All subjects that have been previously investigated at our lab at least 7 years ago

Who may be able to join

  • Participated in previous examination at our lab at least 7 years ago.
  • No blood samples or adipose samples saved from last examination

Who cannot join

  • Decline to participate after invitation.
  • Serious illness or mental disorder.
  • Warfarin or other new oral anticoagulant that increase risk of bleeding.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Lipid laboratory Karolinska University Hospital Huddinge

    Stockholm, Stockholm County, 141 86

Other trials in Sweden

About this study

Official title: Study Of Adipose Tissue Function and Weight Development Over Time

The investigators will study the influence of fat cell size/number and adipose function on weight development over very long time periods (years). By comparing fat biopsies obtained at baseline and after >7 years, the investigators will determine the association between adipose morphology/function and changes in weight or development of cardiometabolic complications (e.g. insulin resistance, 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. The minimal follow up time is 7 years.

Saved blood samples and samples from old fat biopsies will be analyzed together with samples from new examinations.

The investigators plan to examine the subjects in the same way as performed at the baseline examinations. This includes estimation of total body fat using bioimpedance, venous blood samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine secretion.

In selected patients, baseline examinations included DEXA-measurement (dual energy x-ray absorptiometry) for determination of body fat distribution as well as hyperinsulinemic euglycemic clamp. In these cases, the same type of examinations will be repeated at their follow up visits.

Medical subject headings
Obesity, Insulin Resistance, Weight Loss, Weight Gain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight development over time and correlation to adipose morphology

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years (84 months). Weight will be assessed with a regular scale and adipose morphology will be determined by measurement of fat cell size and adjustment for body weight.

    Measured: from 2014 up to 2024, up to 10 years

  2. Weight development and correlation to lipolysis

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale. Fat cells will be isolated and assessment of lipolysis will be made with previously published standardized protocols.

    Measured: 2014 to 2024, up to 10 years

  3. Weight development and correlation to lipogenesis

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Weight will be assessed with a regular scale and lipogenesis will be measured according to previously published standardized protocol after isolated fat cells have been stimulated with insulin.

    Measured: 2014 to 2024, up to 10 years

Secondary outcomes (3)

  1. adipose tissue morphology development and insulin sensitivity

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Insulin sensitivity will be assessed by measurement of glucose and insulin and in some cases also hyperinsulinemic euglycemic clamp.

    Measured: 2014 to 2024, up to 10 years

  2. adipose morphology and changes in fat mass

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Adipose morphology will be determined by measurement of fat cell size and adjustment for body weight. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.

    Measured: 2014 to 2024, up to 10 years

  3. adipose morphology and development of fat mass

    Recruitment of these subjects will continue until 2024 with a minimum follow up time of 7 years. Fat mass will be assessed by impedance measurement and in some cases DEXA according to previously published protocols.

    Measured: 2014 to 2024, up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion1 Mar 2017
  4. Study completion1 Mar 2017

Resources

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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227043
Sponsor's protocol ID
SOWOT
Acronym
SOWOT
Status last verified
Mar 2017
First submitted
22 Aug 2014
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ryden M, Gao H, Arner P. Influence of Aging and Menstrual Status on Subcutaneous Fat Cell Lipolysis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz245. doi: 10.1210/clinem/dgz245.

    PubMed 31784744

  • Arner P, Andersson DP, Backdahl J, Dahlman I, Ryden M. Weight Gain and Impaired Glucose Metabolism in Women Are Predicted by Inefficient Subcutaneous Fat Cell Lipolysis. Cell Metab. 2018 Jul 3;28(1):45-54.e3. doi: 10.1016/j.cmet.2018.05.004. Epub 2018 May 31.

    PubMed 29861390

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Insulin Resistance, run by Karolinska Institutet 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 3 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: finished, as of the sponsor's last update on 3 Mar 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight development over time and correlation to adipose morphology (time frame: from 2014 up to 2024, up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227043, which also lists 2 linked publications.

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 3 Mar 2017.

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