Study Of Weight Development Over Time

Completed

• Conditions: Weight Gain; Obesity; Insulin Resistance; Weight Reduction

• Registration Number: NCT02227043
• Lead Sponsor: Karolinska Institutet

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).

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 Timeline

• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Study Start: 2014-09
• Status Verified: 2017-03
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight development and correlation to lipogenesis	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.
Weight development over time and correlation to adipose morphology	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.
Weight development and correlation to lipolysis	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.

Secondary Outcome Measures

Name	Time	Method
adipose morphology and development of fat mass	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.
adipose morphology and changes in fat mass	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.
adipose tissue morphology development and insulin sensitivity	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.

Trial Locations

Locations (1)

Lipid laboratory Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden