Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03096535
Other study ID # H-16038581-COLDBAT
Secondary ID
Status Completed
Phase N/A
First received February 23, 2017
Last updated March 23, 2018
Start date April 2, 2017
Est. completion date March 1, 2018

Study information

Verified date March 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. A secondary purpose is to make a validation of an infrared thermography camera by comparison of skin temperatures and SUV of the supraclavicular brown adipose tissue.


Description:

The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood and even less is known about the endocrine capacities of human BAT.

Cold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red thermography camera, as well as perform a proteomic screening using blood samples under these two intervention days.

15 healthy lean male subjects will serve as their own control in a cross-over randomized control study, including a pre-examination day, a thermoneutral-day and a cooling test-day with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day is applied for the external validation of the infrared thermography camera. Blood samples and abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of brown fat.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Age 18-30 years.

- Men

- Caucasian white

- Body Mass Index 19-25 kg/m2.

- Moderate physical activity level (not more than 8-10 hours of training pr. Week)

- Ability to give informed consent.

- Ability to follow verbal and written instructions in Danish.

- Body fat percent under 21% measured at the pre-examination day.

Exclusion Criteria:

- Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.

- Tobacco, marijuana or intravenous drug use within 1 year of screening.

- Dieting, recent weight loss (>3 kg within 3 month) or a history of an eating disorder.

- Dietary supplements.

- History of depression, psychosis, or other psychiatric illness requiring hospitalization.

- Alcohol consumption >14 units/week.

- History of alcohol abuse within the past 3 years.

- Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.

- Known kidney disease or elevated kidney biomarkers, eCRF <60 ml/min, in the preliminary investigation.

- Use of daily medications, except for seasonal use of antihistamines.

- Diagnosed sleep disturbances.

- Pacemaker or other electronics implanted in the body.

- Magnetic impressionable metal implants or foreign objects in the body inconsistent with completion of MR.

- Claustrophobia

- Communication problems, including understanding the experimental protocol

- History of contrast allergy.

- Winter swimmers.

Study Design


Intervention

Procedure:
Cooling
Individualized cooling protocol.
Thermoneutral
Thermoneutral control day.

Locations

Country Name City State
Denmark Center for Inflammation and Metabolism/ Center for Physical Activity Research Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Susanna Søberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in brown adipose tissue (BAT) activity after cooling versus no cooling. BAT activity is measured by standard fluorodeoxyglukose uptake volume (SUV mean) in the supraclavicular BAT depot using PET/MR scans. Difference between scans performed after 2 hours of cooling and 2 hours of no cooling is calculated. Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.
Secondary Difference in BAT activity after cooling versus no cooling. BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling and 2 hours of no cooling is calculated. Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling.
Secondary Difference in resting energy expenditure after cooling versus no cooling Difference in resting energy expenditure after cooling versus no cooling, measured as mean difference in KJ/min. Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2