Nicotinamide Adenine Dinucleotide (NAD+) Metabolism in Human Brown Adipose Tissue (NCT06627868) | Clinical Trial Compass
RecruitingNot Applicable
Nicotinamide Adenine Dinucleotide (NAD+) Metabolism in Human Brown Adipose Tissue
Finland68 participantsStarted 2024-11-20
Plain-language summary
A fully functional brown fat helps maintain a healthy weight and decreases the risk of metabolic diseases such as type II diabetes (T2DM). Unfortunately, in human adults, the functionality of brown fat declines with age, and it is one of the reasons for gaining unhealthy weight, particularly around the waistline (central obesity). Currently, scientists do not clearly understand the reasons for the decline in brown fat functionality. It is possible that the decline in the availability of the molecule Nicotinamide Adenine Dinucleotide (NAD+), which is central to several metabolic processes, plays a role in the decline in brown fat metabolism. This project will clarify whether NAD+-based molecular-targeted therapies for the enhancement of whole-body insulin sensitivity and brown fat metabolism will be successful in adult humans, which will eventually be an important target for reducing the development of obesity and its comorbidities such as T2DM.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willingness to provide informed consent to participate in the BATNAD study
* Must be able to read and speak English/Finnish/Swedish well enough to completely understand the instructions and provide informed consent
* Age 30-55 (sedentary lifestyle)
* BMI = 18-25 kg/m2 (normal-weight subjects)
* BMI ≥ 28 kg/m2 and waist circumference more than 100 cm in men and more than 90 cm in women (subjects with obesity)
Exclusion Criteria:
* Inability to have PET/CT (claustrophobia, metal implants, recent tattoo including metal components, weight \> 200 kg)
* Pregnancy and pregnancy related conditions (postpartum/lactation during the last 12 months, or planning to become pregnant soon)
* Major alterations in the menstrual cycle (e.g., amenorrhea)
* Use of nicotine based products
* Hypo- or hyper- thyroidism (medical history, TSH, T3 or T4 levels out of the normal range)
* Diabetes mellitus (fasting Hb1Ac \>6.5% or fasting glycaemia\> 7.0 mmol/)
* Abnormal oral glucose tolerance test (2h OGTT \> 11.1 mmol/L)
* Hypertension (blood pressure \> 160/100 mmHg)
* Abnormal cardiovascular status (arrhythmia and/or long QTc in ECG, abnormal cardiac murmur, previous history of cardiovascular disease)
* Abnormal coagulopathy (e.g., clotting abnormality)
* Malignancies
* Immunological, autoimmune and primary/secondary immunodeficiency disorders (including or not any active treatment)
* Virus or bacterial infection (both asymptomatic and symptomatic picture) wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.