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Trial record 1 of 1 for:    SOWOT
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Study Of Weight Development Over Time (SOWOT)

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ClinicalTrials.gov Identifier: NCT02227043
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Mikael Ryden, Karolinska Institutet

Study Description
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Brief 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 weight or development of cardiometabolic complications (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).

Condition or disease
Obesity Insulin Resistance Weight Reduction Weight Gain

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.

Study Design
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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Of Adipose Tissue Function and Weight Development Over Time
Study Start Date : September 2014
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Weight development over time and correlation to adipose morphology [ Time Frame: from 2014 up to 2024, up to 10 years ]
    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.

  2. Weight development and correlation to lipolysis [ Time Frame: 2014 to 2024, up to 10 years ]
    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.

  3. Weight development and correlation to lipogenesis [ Time Frame: 2014 to 2024, up to 10 years ]
    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.


Secondary Outcome Measures :
  1. adipose tissue morphology development and insulin sensitivity [ Time Frame: 2014 to 2024, up to 10 years ]
    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.

  2. adipose morphology and changes in fat mass [ Time Frame: 2014 to 2024, up to 10 years ]
    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.

  3. adipose morphology and development of fat mass [ Time Frame: 2014 to 2024, up to 10 years ]
    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.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, adipose tissue, adipocytes

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Observational study All subjects that have been previously investigated at our lab at least 7 years ago
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Decline to participate after invitation.
  • Serious illness or mental disorder.
  • Warfarin or other new oral anticoagulant that increase risk of bleeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227043


Locations
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Sweden
Lipid laboratory Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Region Stockholm
Investigators
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Principal Investigator: Mikael Ryden, MD, PhD Karolinska Institutet
Study Director: Peter Arner, MD, PhD Karolinska Institutet
Study Chair: Daniel P Andersson, MD Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mikael Ryden, MD, PhD, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02227043    
Other Study ID Numbers: SOWOT
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Insulin Resistance
Body Weight
Weight Gain
Weight Loss
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight Changes