- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06078345
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis (BANDIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this prospective interventional study healthy individuals will be screened for presence of active BAT: Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects (n=15) and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects (n=15) and then take part in three study visits in random order.
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A) glucose (OGTT) B) fat and C) protein.
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours. Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose, triglycerides, FAAs, representative amino acids, insulin and noradrenaline.
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthias J Betz, MD
- Phone Number: 0041 61 556 56 54
- Email: matthias.betz@usb.ch
Study Locations
-
-
-
Basel, Switzerland
- Recruiting
- University Hospital Basel, Dept. of Endocrinology
-
Contact:
- Laila Füchtbauer, MD
- Email: laila.fuechtbauer@usb.ch
-
Sub-Investigator:
- Laila Füchtbauer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI 18.5 to 28 kg/m2
- Able to give informed consent as documented by signature
Exclusion Criteria:
- Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- Hyper- or hypothyroidism
- Smoker / habitual tobacco use
- Weight change of >5% within 3 months prior to inclusion
- Hypersensitivity to cold (e.g. Raynaud syndrome)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Enrolment into another study using ionizing radiation within the previous 12 months
- Enrolment into another study including a pharmacological or nutritional intervention
- Pregnancy or lactation
Lab parameters
- Serum-Creatinine: above 1.5x upper limit of normal (ULN)
- Glycated Hemoglobin (HbA1c): above 6.0%
- Random plasma glucose >11 mM
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BAT positive
Maximal activated supraclavicular BAT SUVmean >1,5 g/ml-
|
400 Kcal glucose (100g oGTT)
400 Kcal glucose rapeseed oil.
400 Kcal Moltein PURE (111g)
|
Experimental: BAT negative
Maximal activated supraclavicular BAT SUVmean <1,5 g/ml
|
400 Kcal glucose (100g oGTT)
400 Kcal glucose rapeseed oil.
400 Kcal Moltein PURE (111g)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC Glucose
Time Frame: 1h before and 5 hours after nutritional intervention
|
Area under the curve (AUC) of glucose after the oral glucose load in participants with functional BAT as compared to participants without functional BAT
|
1h before and 5 hours after nutritional intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC Branched chain amino acids
Time Frame: 1h before and 5 hours after nutritional intervention
|
AUC of BCAAs after protein load in in participants with functional BAT as compared to participants without functional BAT
|
1h before and 5 hours after nutritional intervention
|
AUC triglycerides
Time Frame: 1h before and 5 hours after nutritional intervention
|
AUC of plasma triglycerides after lipid test meal in participants with functional BAT as compared to participants without functional BAT.
|
1h before and 5 hours after nutritional intervention
|
Diet induced thermogenesis
Time Frame: 1h before and 5 hours after nutritional intervention
|
Diet-induced thermogenesis: AUC of EE above RMR in response to the respective macronutrient (carbohydrate, protein or fat).
Measured by indirect calorimetry.
The results for each macronutrient will be compared between the BAT positive and BAT negative participants.
|
1h before and 5 hours after nutritional intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthias J Betz, MD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ 2023-01544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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