NCT04037371

Brief Summary

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. The investigators aimed to identify whether human WAT thermogenic activation could alter energy homeostasis and subsequently total body weight. The human WAT thermogenic capacity was assessed via Positron Emission Tomography/Computed Tomography (PET/CT) examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

July 22, 2019

Last Update Submit

July 25, 2019

Conditions

Keywords

Cold exposurewhite fat cellsthermoregulationwinter

Outcome Measures

Primary Outcomes (1)

  • Correlation between white adipose tissue activity and environmental temperature. Mean differences in white adipose tissue activity between those participants who were assessed in winter and those who were assessed in summer.

    White adipose tissue activity was assessed using a PET/CT examination to calculate the standardized uptake value (SUV) in dorsolumbar region near vertebrae L3 and abdominal region. Daily environmental temperature was obtained in degrees Celsius from the Weather Underground (www.wunderground.com) webpage for the period between January 2017 and February 2019

    An overall of 10 hours of an assessment period that including two hours of cold exposure, 30 minutes of resting energy expenditure and 40 minutes of PET/CT assessments

Interventions

Participants were tested for white fat thermogenic activity against their environmental temperature exposure

Eligibility Criteria

AgeUp to 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 healthy adult men \[age: 36.30±5.33 (years); Body Mass Index: 28.46±5.49 (kg/m2)\]

You may qualify if:

  • healthy adult men
  • no chronic disease
  • not being under medication treatment
  • non-smoking individuals
  • non-regular exercisers individuals

You may not qualify if:

  • non-adult men
  • women
  • chronic disease
  • being under medication treatment
  • smokers
  • regular exercisers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petros Dinas

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

ObesityObesity, Abdominal

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Flouris, PhD

    FAME Laboratory, Department of Exercise Science, University of Thessaly

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher in human physiology

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 30, 2019

Study Start

April 2, 2017

Primary Completion

January 16, 2018

Study Completion

March 30, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations