Study Of Weight Development Over Time

Obesity Clinical Trial

— SOWOT  

Official title:

Study Of Adipose Tissue Function and Weight Development Over Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227043
• Other study ID #: SOWOT
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: March 1, 2017
• Start date: September 2014
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance
• Obesity
• Weight Gain
• Weight Loss
• Weight Reduction

Locations

Country	Name	City	State
Sweden	Lipid laboratory Karolinska University Hospital Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from 2014 up to 2024, up to 10 years
Primary	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.	2014 to 2024, up to 10 years
Primary	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.	2014 to 2024, up to 10 years
Secondary	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.	2014 to 2024, up to 10 years
Secondary	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.	2014 to 2024, up to 10 years
Secondary	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.	2014 to 2024, up to 10 years