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NCT Number: NCT02227043

Study Of 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).

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Key information

Conditions

Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Weight Loss Weight Reduction

Age range

24 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lipid laboratory Karolinska University Hospital Huddinge

Stockholm, Stockholm County, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Study Of Adipose Tissue Function and Weight Development Over Time

Acronym: SOWOT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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