Brown adipose tissue and bile acids

Conditions: Healthy subjects
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-002512-27-NL

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Caucasians
- Age: 18-30 years
- Gender: male and female (females only on a specific oral contraceptive pill; microgynon 30 or
levonorgestrel/ethinylestradiol)
- BMI: 18-25 kg/m2
- Good general health
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Psychologically unstable subjects (as judged by the treating medical specialist)
- Subjects with mental retardation (as judged by the treating medical specialist)
- Subjects with severe behavior disorders (as judged by the treating medical specialist)
- Pregnancy or lactation
- The use of the following medication one month before the study is an exclusion criterium; ß-blockers,
ursodeoxycholic acid, bile acid sequestrants, antacids
- Participation in an intensive weight-loss program or vigorous exercise program during the last year before the
start of the study
- Abuse of drugs and/or alcohol
- Severe diabetes which requires application of insulin or patients with diabetes-related complications
- Surgery of the gastro-intestinal tract (only appendectomy is allowed)
- Previous ERCP with papillotomy
- History of cholesystectomy or disease of the gallbladder, biliary system and/or liver
- Hyperthyroidism or hypothyroidism
- BMI > 25 kg/m2
- Participation in earlier research or medical examinations that included PET/CT scanning

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of bile acids on brown adipose tissue activity and energy expenditure in humans.;Secondary Objective: The effect of bile acids on<br>- skin temperature<br>- body core temperature<br>- skin perfusion<br>- mitochondrial respiration in skeletal muscle<br>- browning of white adipocytes;Primary end point(s): - Brown adipose tissue activity<br>- Energy expenditure;Timepoint(s) of evaluation of this end point: Directly after the measurements

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - skin temeprature<br>- body core temperature<br>- skin perfusion<br>- mitochondrial respiration in myocytes<br>- ' browning' of white fat;Timepoint(s) of evaluation of this end point: Directly after measurements