NCT02227043

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

August 22, 2014

Last Update Submit

March 1, 2017

Conditions

ObesityInsulin ResistanceWeight ReductionWeight Gain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • adipose tissue morphology development and insulin sensitivity

    2014 to 2024, up to 10 years

  • adipose morphology and changes in fat mass

    2014 to 2024, up to 10 years

  • adipose morphology and development of fat mass

    2014 to 2024, up to 10 years

Eligibility Criteria

Age24 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lipid laboratory Karolinska University Hospital Huddinge

Stockholm, Stockholm County, 141 86, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 31784744DERIVED

  • 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.

    PMID: 29861390DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, adipose tissue, adipocytes

MeSH Terms

Conditions

ObesityInsulin ResistanceWeight LossWeight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight Changes

Study Officials

  • Mikael Ryden, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Peter Arner, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

  • Daniel P Andersson, MD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 27, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

SE(1)