CompletedNot Applicable

Brown Adipose Tissue Metabolism in Type 2 Diabetes

Canada6 participantsStarted 2021-05-18

Plain-language summary

Activation of brown adipose tissue (BAT) by cold exposure. BAT thermogenesis and BAT volume of metabolic activity will be assessed by Positron-Emitting-Tomography (PET/CT) and MRI/MRS imaging and new pharmacological methods to modulate BAT thermogenesis. All previous data on the functioning of Brown Adipose Tissue (BAT) were obtained by Positron-Emitting-Tomography (PET) imaging studies using fluorodeoxyglucose F18 ( \[18F\]- FDG). This approach underestimates the actual activity of the BAT. In this study, the investigator is going to use a new PET tracer (C11-palmitate) which is a fat molecule. This will allow to quantify more accurately the activity of brown fat.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 10 men and 10 women with T2D. * 10 non-diabetic men and 10 non-diabetic women (matched for sex, BMI and age to the T2D participants). Exclusion Criteria: * Change in weight of more than 2 kg over the past 3 months or recent changes in lifestyle; * Treatment with a fibrate, thiazolidinedione, insulin, beta-blocker, GLP-1 agonist, or other drug known to affect lipid or carbohydrate metabolism, except statins, metformin, sulfonylurea, DPP-IV inhibitor and other antihypertensive agents that can be temporarily stopped safely prior to the studies, as per our approved protocols; * Presence of overt cardiovascular, liver, renal or other medical conditions; * Smoking or consumption of more than 2 alcoholic beverages per day; * Any other contraindication to temporarily suspending current medications for lipids or hypertension; * Any contraindication to MRI scanning. * Having participated to a research study with exposure to radiation in the last two years before the start of the study.

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.

What they're measuring

BAT volume

Timeframe: 180 minutes after the start of the cold exposure

Brown Adipose Tissue (BAT) Glucose uptake

Timeframe: 150 minutes after the start of the cold exposure

Trial details

NCT IDNCT05092945

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-10

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