NCT03811236Recruiting
Cold-induced Brown Fat Activation and Hepatic Steatosis
Source: ClinicalTrials.gov · Last updated 13 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and activity during these studies. These changes were accompanied by improvements in body fat mass as well as insulin sensitivity. Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation. The aim of this study is to investigate whether BAT recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with NAFLD.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 18 Jan 2019
- Start date
- 21 Jan 2019
- Primary completion date
- Dec 2025
- Lead sponsor
- Medical University of Vienna
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT03811236
What you commit to
- Study type: Interventional
- Planned participants: 26
- From 21 Jan 2019 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- chronic kidney disease
- inflammatory bowel disease
- active malignant disease
- autoimmune disease
- positive serology for autoimmune hepatitis
- positive hepatitis serology
- portal hypertension
Lab values
- endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (\<500 mg/dl) and untreated type II diabetes mellitus (fasting glucose \< 140 mg/dl)
- serum alpha-1 antitrypsin \< 90 mg/dl
- serum ceruloplasmin \< 20 mg/dl
Other
- use of beta-blockers, alpha-blockers and rilmenidine
- chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for women
- transferrin saturation \> 40%
- liver cirrhosis
- pregnancy
- contraindications for magnetic resonance imaging
Who the study is looking for
- body mass index 28 - 40 kg/m\^2
- hepatic lipid content \> 10 %
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.