Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-05-18
2025-12-31
Brief Summary
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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.
Detailed Description
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PET/ MRI studies will be performed with and without nicotinic acid. A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg, through V2 (protocol A): one dose at time 0, 60 minutes, 120 minutes and 180 minutes.
During V2 and V3, participants will undergo Acute Cold Exposure to stimulate brown adipose tissue.
The morning of each PET imaging study, the participants will follow an MRI acquisition to determine hepatic, pancreatic, visceral and BAT lipid content, followed by an MRS acquisition in the hepatic and cervico-thoracic region. MRI and MRS acquisition of the hepatic and cervico-thoracic region will be repeated again at the end of the day.
The radioactive PET tracers used in this study are the \[11C\]-acetate, \[11C\]-palmitate and \[18F\]-FDG followed by dynamic and whole-body scans.
Stable isotopes such as \[U-13C\]-palmitate (0.08 umol/kg/min), 5D-glycérol (0.1 µmol/kg/min,) and tritiated glucose (of 1.5 uCi/min) will be perfused from the start of the day until time 180 min.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Subject with Type 2 Diabetes- cold exposure
3-hour cold exposure: Protocol B
Cold exposure
The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
Subject with type 2 Diabetes- cold exposure and nicotinic acid
3-hour cold exposure with oral nicotinic acid: Protocol A
Cold exposure
The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
Oral Nicotinic acid
A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg: one dose of 150 mg at time 0 and 60 minutes, one dose of 100 mg at time 120 minutes and 180 minutes.
Subject without Type 2 Diabetes- cold exposure
3-hour cold exposure: Protocol B
Cold exposure
The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
Subject without type 2 Diabetes- cold exposure and nicotinic acid
3-hour cold exposure with oral nicotinic acid: Protocol A
Cold exposure
The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
Oral Nicotinic acid
A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg: one dose of 150 mg at time 0 and 60 minutes, one dose of 100 mg at time 120 minutes and 180 minutes.
Interventions
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Cold exposure
The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.
Oral Nicotinic acid
A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg: one dose of 150 mg at time 0 and 60 minutes, one dose of 100 mg at time 120 minutes and 180 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 10 non-diabetic men and 10 non-diabetic women (matched for sex, BMI and age to the T2D participants).
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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André Carpentier
tenured professor
Principal Investigators
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André Carpentier
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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Centre de recherche du CHUS
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Frédérique Frisch
Role: primary
Other Identifiers
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2019-2990
Identifier Type: -
Identifier Source: org_study_id