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Clinical Trials/NCT04787952
NCT04787952CompletedNot Applicable

Searching for the New Mechanisms That Activate Brow Fat Tissue

Medical University of Bialystok0 sites40 target enrollmentStarted: October 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Primary Endpoint
The potential associations between BAT activity and dietary intake

Study Overview

Brief Summary

The general purpose of the study was to provide new information about the role of macronutrients intake, metabolomics, proteomics and microRNA on BAT activation.

The invesigator evaluated BAT activity and whole body energy consumption under cold stimulation in two gruops of healthy males aged 21-43 years old with normal BMI ( 19-25kg/m2) and in overweight/obese subjects.

Detailed Description

In detail, the main objectives of this study was to measure the influence of biological molecules of such fields: genomics, transcriptomics metabolomics and protemics and its relationship on BAT activation. The investigator also evaluated the role of diet, macronutirnets intake and polyunsaturated fatty acids on BAT activity.

Study design:

  1. SCREENING VISIT:
  • obtaining written informed consent from all subjects
  • physical examination
  • body composition analysis ( DXA + bioindepedance method inbody 720)

Laboratory analyses:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 43 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Inclusion criteria to the group 1 (healthy males) N=20:
  • BMI <25 kg/m2;
  • RR<140/90mmHg;
  • age 20-30/40 years
  • fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;
  • no chronic disease
  • Inclusion criteria to the group 2 ( overweight/obese males) N=20:
  • Blood pressure < 140/90 mmHg (well controlled by inh ACE; no beta-blockers)
  • No chronic disease
  • BMI > 25 <35kg/m²
  • fasting glycemia <100mg/dl; 2h-OGTT <140mg/dl;

Exclusion Criteria

  • Any drug use: beta-blokers, statins, glucocorticoids drugs, hypertension drugs;
  • hypertension;
  • hormonal disorders;
  • Inflammation process
  • Claustrophobia

Outcomes

Primary Outcomes

The potential associations between BAT activity and dietary intake

Time Frame: 2016-2018

The relationship between BAT activity and dietary intake will be analyzed

The potential associations between BAT activity and metabolite profile

Time Frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure

The potential molecules will be identified by metabolomics approach and will be analyzed dependently on the brown tissue activity level

The potential associations between BAT activity and proteins profile

Time Frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure

The potential molecules will be identified by proteomics approach and will be analyzed dependently on the brown tissue activity level

The potential associations between BAT activity and transcriptome profile

Time Frame: the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure

The potential molecules will be identified by transriptomics approach and will be analyzed dependently on the brown tissue activity level

Secondary Outcomes

  • The potential associations between BAT activity and irisin concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and atrial natiuretic peptide concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and fT3 concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and Interleukin-6 concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and FFA ( free fatty acids) concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and energy expenditure(at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure)
  • The potential associations between BAT activity and glucose concentrations(he baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and TSH concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and substrates utilization(at the baseline ( -30 min to 0 min) and every 30 min until 120 min of cold exposure.)
  • The potential associations between BAT activity and insulin concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and brain natiuretic peptide concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and plasma nonesterified fatty acid concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposure)
  • The potential associations between BAT activity and fT4 concentrations(the baseline (before cold exposure) and after 1st hour and 2nd hour of cold exposu)

Investigators

Sponsor
Medical University of Bialystok
Sponsor Class
Other
Responsible Party
Sponsor

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