Insight Into New Brown Adipose Tissue Activators.

NCT04787952 | Completed

• 1 other identifier: UMB24/02/2021
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adiposity; Metabolic Complication; Metabolic Disturbance; Healthy; Obesity; Diet Habit; Nutritional and Metabolic Diseases

Keywords

brown adipose tissue, obesity, diabetes type 2

Outcome Measures

Primary Outcomes (4)

• The potential associations between BAT activity and dietary intake

  The relationship between BAT activity and dietary intake will be analyzed

  2016-2018

• The potential associations between BAT activity and metabolite profile

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

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

• The potential associations between BAT activity and proteins profile

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

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

• The potential associations between BAT activity and transcriptome profile

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

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

Secondary Outcomes (13)

• 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 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 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 glucose concentrations

  he baseline (before cold exposure) and after 1st hour and 2nd hour 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

Study Arms (2)

Group 1= healthy subjects

Inclusion criteria to the group 1 (healthy males) N=20: 1. BMI \<25 kg/m2; 2. RR\<140/90mmHg; 3. age 21-43 years 4. fasting glycemia \<100mg/dl; 2h-OGTT \<140mg/dl; 5. no chronic disease

Other: cold expossure

Group 2 = overweight/obese subjects

Inclusion criteria to the group 2 ( overweight/obese males ) N=20: 1. Blood pressure \< 140/90 mmHg (well controlled by inh ACE; no beta-blockers) 2. No chronic disease 3. BMI \> 25 \<35kg/m² 4. fasting glycemia \<100mg/dl; 2h-OGTT \<140mg/dl; 5. age 21-43 years

Other: cold expossure

Interventions

cold expossure OTHER

subjects were exposed for the cold, to activate and diagnose potential brown tissue activity

Group 1= healthy subjects; Group 2 = overweight/obese subjects

Eligibility Criteria

• Age: 20 Years - 43 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study group comprised of 28 young, healthy, non - smoking Caucasian males, aged 21-42 years (mean age 26.75 ±5.11 years old), 16 with normal body weight (BMI \< 25 kg/m2) and 12 obese/overweight (BMI \> 25 kg/m2). Only participants without any comorbidities (e.g. hypo- and hyperthyroidis, asthma, cardiovascular disease, renal and liver failure, etc.) as well as without any medications (beta-blockers etc.) that could have impact on results, were enrolled to the study. Outside and shift workers have been excluded from the study as well.

You may qualify if:

• BMI \<25 kg/m2;
• RR\<140/90mmHg;
• age 20-30/40 years
• fasting glycemia \<100mg/dl; 2h-OGTT \<140mg/dl;
• no chronic disease
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Bialystok: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Obesity; Feeding Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Katarzyna Maliszewska, PhD

  Medical University of Bialystok, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: October 1, 2016
• Primary Completion: February 24, 2018
• Study Completion: February 24, 2018
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Data maybe shared upon reasonable request and according with the Medical University of Bialystok condition.