Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women

NCT06426082 | Not Yet Recruiting

• 1 other identifier: PID2022-141442OA-I00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate specific brown and beige fat cells in the dorsocervical area of young, lean adult women. Participant Population/Health Conditions: The study will involve 40 young, lean adult women. Main Questions: The main questions this study aims to answer are:

• Are there active brown or beige adipocytes in the subcutaneous fat of the dorsocervical area (i.e., iBAT)?
• What is the secretory function of these adipocytes?
• How do traditional interventions like cold exposure, as well as new approaches like Beta-2 agonist stimulation and exercise, affect the thermogenesis of these fat cells at the cellular and molecular levels? Participants Will: Be randomized into one of four groups: thermoneutral exposure, cold exposure, aerobic exercise, or Beta-2 agonist treatment. Follow their assigned regimen for 4 weeks. Provide tissue samples from the dorsocervical area and abdomen before and after the 4-week intervention. Undergo analysis of these samples using advanced techniques to understand the presence and activity of brown and beige fat cells. Comparison Group: Researchers will compare the effects of different interventions (thermoneutral exposure, cold exposure, aerobic exercise, Beta-2 agonist treatment) on the presence and thermogenesis of brown and beige fat cells in the dorsocervical area.

Conditions

Cardiometabolic Diseases

Keywords

brown adipose tissue; cold exposure; hot exposure; dorsocervical fat; exercise

Outcome Measures

Primary Outcomes (1)

• Change in UCP1 expression in the dorsocervical area

  Investigators will quantify the level UCP1 expression by qPCR in white adipose tissue biopsies obtained before and after the intervention

  2 years

Secondary Outcomes (8)

• Body composition (BIA, Tanita)

  2 years

• Cardiorespiratory fitness test (indirect calorimetry and monarch bike)

  2 years

• LDL quantification in blood

  2 years

• HDL quantification in blood

  2 years

• Glucose quantification in blood

  2 years

Study Arms (4)

Thermoneutral condition

PLACEBO COMPARATOR

n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week; Total 4 weeks

Behavioral: Thermoneutral condition

Cold condition

EXPERIMENTAL

n=10; receiving 2 hours/day at 18ºC; 5 days/week; Total 4 weeks

Behavioral: Cold condition

Salbutamol

EXPERIMENTAL

n=10; salbutamol 12 mg/day. 7 days week. Total 4 weeks

Drug: Salbutamol

Aerobic exercise

EXPERIMENTAL

n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session. Total 4 weeks

Behavioral: Aerobic exercise condition

Interventions

Thermoneutral condition BEHAVIORAL

Participants will be exposed 2 hours/day at 32ºC for 5 days/week

Thermoneutral condition

Cold condition BEHAVIORAL

Participants will be exposed 2 hours/day at 18ºC for 5 days/week

Cold condition

Aerobic exercise condition BEHAVIORAL

Participants will perform aerobic exercise training 5 days/week at 65% heart rate reserve for 60 minutes each training session

Aerobic exercise

Salbutamol DRUG

Participants will take salbutamol 12 mg/day. 7 days week

Salbutamol

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age women.
• BMI between ≥18 and \<25 kg/m2
• Are willing to be randomized to either of these 4 groups.
• Must be sedentary (i.e., do not perform exercise or go to the gym).
• Participants should have regular menstrual cycles.
• Must be willing to adhere to all study procedures, including attendance at all study visits.
• Must be willing to have biological samples stored for future research.
• Must accept the use of the Period Calendar and Google Fit Apps on their mobile phones.

You may not qualify if:

• Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria).
• Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia).
• Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure).
• Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids).
• Use of medication shown to increase risk of hypokalemia after salbutamol administration (e.g., xanthine derivatives, steroids and diuretics).
• Clinically relevant abnormalities in clinical chemistry or electrocardiogram (ECG) at screening (to be judged by the study physician).
• A first-degree family member with sudden cardiac death.
• Any chronic renal or hepatic disease.
• Any other contra-indications for the use of salbutamol or propranolol.
• Abuse of alcohol or other substances.
• Smoking.
• Current participation in another research projects that may influence the current research project.
• Use of beta-adrenergic receptor agonists (e.g., asthma).
• Polycystic ovary syndrome.
• Diagnosed psychotic conditions.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Leiden University Medical Center: collaborator
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

Universidad de Almería

Almería, 04131, Spain

Location

Related Publications (1)

• Martinez-Tellez B, Sanchez-Delgado G, Alcantara JMA, Acosta FM, Amaro-Gahete FJ, Osuna-Prieto FJ, Perez-Bey A, Jimenez-Pavon D, Llamas-Elvira JM, Gil A, Aguilera CM, Rensen PCN, Ruiz JR. Evidence of high 18 F-fluorodeoxyglucose uptake in the subcutaneous adipose tissue of the dorsocervical area in young adults. Exp Physiol. 2019 Feb;104(2):168-173. doi: 10.1113/EP087428. Epub 2018 Dec 18.

  PMID: 30468689 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Central Study Contacts

Borja Martinez Tellez, PhD

CONTACT

+34 950215334; borjammt@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will consist of a randomized controlled trial in which forty young, lean women will be assigned to a control group (n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week) or a cold exposure group (n=10; receiving 2 hours/day at 18ºC; 5 days/week) or aerobic exercise group (n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session) or an ADBR2 agonist ingestion (n=10; salbutamol 12 mg/day. 7 days week).

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: May 23, 2024
• Study Start: November 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 5 years after publishing the data
• Access Criteria: Everybody

Locations

ES (1)