Cardiometabolic Diseases Clinical Trial
— DEBATEOfficial title:
Deciphering the Molecular and Secretory Functions of a Novel and Unique Brown Adipose Tissue Depot in Women
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | August 2026 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 22 Years |
Eligibility | Inclusion Criteria: - 18-22 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Almería | Almería |
Lead Sponsor | Collaborator |
---|---|
Universidad de Almeria | ETH Zurich (Switzerland), Leiden University Medical Center |
Spain,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Body composition (BIA, Tanita) | Change in fat percentage (% of fat) | 2 years | |
Secondary | Cardiorespiratory fitness test (indirect calorimetry and monarch bike) | Change in VO2max (ml/kg/min) | 2 years | |
Secondary | LDL quantification in blood | Change in LDL-C (mg/dL) | 2 years | |
Secondary | HDL quantification in blood | Change in HDL-C (mg/dL) | 2 years | |
Secondary | Glucose quantification in blood | Change in Glucose (mg/dL) | 2 years | |
Secondary | Insulin quantification in blood | Change in Insulin (µIU/mL) | 2 years | |
Secondary | Triglycerides quantification in blood | Change in Triglycerides (mg/dL) | 2 years | |
Secondary | C-reactive protein quantification in blood | Change in CRP (mg/L) | 2 years |
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