Type 2 DiabetesGB8NCT05092945
Brown Adipose Tissue Metabolism in Type 2 Diabetes
A study testing Cold exposure and Oral Nicotinic acid in people with Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cold exposure and Oral Nicotinic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2021to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Brown Adipose Tissue Thermogenesis in Type 2 Diabetes
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.
Read the detailed description
The study protocol includes three visits: the screening visit (V1) and two PET/MRI imaging studies (V2 and V3) performed in random order at an interval of 7 to 14 days.
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
- Type 2 Diabetes
- Being tested
- Cold exposure, Oral Nicotinic acid
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
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 acidDrug
Also called Niacin 500 (Jamp Pharma) NPN 00557412
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.
| Study group | Role | What they receive |
|---|---|---|
| Subject with Type 2 Diabetes- cold exposure | Active comparator | 3-hour cold exposure: Protocol B Receives: Other: Cold exposure |
| Subject with type 2 Diabetes- cold exposure and nicotinic acid | Experimental | 3-hour cold exposure with oral nicotinic acid: Protocol A Receives: Other: Cold exposure; Drug: Oral Nicotinic acid |
| Subject without Type 2 Diabetes- cold exposure | Active comparator | 3-hour cold exposure: Protocol B Receives: Other: Cold exposure |
| Subject without type 2 Diabetes- cold exposure and nicotinic acid | Experimental | 3-hour cold exposure with oral nicotinic acid: Protocol A Receives: Other: Cold exposure; Drug: Oral Nicotinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT volume
Assessed using i.v. injection of 18FDG with whole-body PET/CT acquisition.
Measured: 180 minutes after the start of the cold exposure
Brown Adipose Tissue (BAT) Glucose uptake
Assessed using i.v. injection of 18FDG with sequential dynamic PET/CT scanning
Measured: 150 minutes after the start of the cold exposure
Secondary outcomes (7)
Activation of BAT (oxidative metabolism)
Measured with 11C-acetate using dynamic PET/CT acquisition.
Measured: 90 minutes after beginning cold exposure
Fatty Acid uptake and metabolism
Measured with 11C-palmitate using dynamic PET/CT acquisition.
Measured: at baseline and at time 120 minutes after beginning cold exposure
BAT triglyceride content
Estimated by CT and MR using 1H-MRS and Dixon sequences on a 3T clinical MRI system.
Measured: at baseline and at time 180 (for CT) and 240 (for MR) after cold exposure.
Whole-body lipolysis
Systemic appearance rate of glycerol and fatty acid determined by perfusion of [1,1,2,3,3-2H]-glycerol, [U-13C]-palmitate tracers and concentration of total NEFA, triglycerides, palmitate, oleate, linoleate, glycerol.
Measured: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Hepatic Glucose production
Systemic appearance rate of glucose determined by perfusion of [3-3H]-glucose.
Measured: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Substrate utilisation
VO2 and VCO2 will be measured by indirect calorimetry to calculate carbohydrate and fatty acid oxidation rates.
Measured: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Changes in insulin level and secretion
measured with ELISA and Milliplex.
Measured: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start18 May 2021
- Primary completion10 Feb 2022
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups in parallel (with and without Type 2 diabetes). In each group, the protocol will be carried out as a within-subject, randomized, cross-over study in which each subject will serve as his/her own control.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André Carpentier, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092945
- Sponsor's protocol ID
- 2019-2990
- Acronym
- GB8
- Status last verified
- Feb 2026
- First submitted
- 19 May 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Brown Adipose Tissue Thermogenesis in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05092945
- Acronym / sponsor ID
- GB8 / 2019-2990
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study protocol includes three visits: the screening visit (V1) and two PET/MRI imaging studies (V2 and V3) performed in random order at an interval of 7 to 14 days.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two groups in parallel (with and without Type 2 diabetes). In each group, the protocol will be carried out as a within-subject, randomized, cross-over study in which each subject will serve as his/her own control.
| Arm | Type | Receives |
|---|---|---|
| Subject with Type 2 Diabetes- cold exposure | Active comparator | Other: Cold exposure3-hour cold exposure: Protocol B |
| Subject with type 2 Diabetes- cold exposure and nicotinic acid | Experimental | Other: Cold exposure, Drug: Oral Nicotinic acid3-hour cold exposure with oral nicotinic acid: Protocol A |
| Subject without Type 2 Diabetes- cold exposure | Active comparator | Other: Cold exposure3-hour cold exposure: Protocol B |
| Subject without type 2 Diabetes- cold exposure and nicotinic acid | Experimental | Other: Cold exposure, Drug: Oral Nicotinic acid3-hour cold exposure with oral nicotinic acid: Protocol A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold exposureThe 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. | Other | Subject with Type 2 Diabetes- cold exposure, Subject with type 2 Diabetes- cold exposure and nicotinic acid, Subject without Type 2 Diabetes- cold exposure, Subject without type 2 Diabetes- cold exposure and nicotinic acid |
| Oral Nicotinic acidAlso: Niacin 500 (Jamp Pharma) NPN 00557412A 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. | Drug | Subject with type 2 Diabetes- cold exposure and nicotinic acid, Subject without type 2 Diabetes- cold exposure and nicotinic acid |
Primary outcome
BAT volume
Time frame: 180 minutes after the start of the cold exposure
Assessed using i.v. injection of 18FDG with whole-body PET/CT acquisition.
Brown Adipose Tissue (BAT) Glucose uptake
Time frame: 150 minutes after the start of the cold exposure
Assessed using i.v. injection of 18FDG with sequential dynamic PET/CT scanning
7 secondary outcomes
Activation of BAT (oxidative metabolism)
Time frame: 90 minutes after beginning cold exposure
Fatty Acid uptake and metabolism
Time frame: at baseline and at time 120 minutes after beginning cold exposure
BAT triglyceride content
Time frame: at baseline and at time 180 (for CT) and 240 (for MR) after cold exposure.
Whole-body lipolysis
Time frame: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Hepatic Glucose production
Time frame: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Substrate utilisation
Time frame: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Changes in insulin level and secretion
Time frame: -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Carpentier principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold exposure and Oral Nicotinic acid in people with Type 2 Diabetes, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT volume (time frame: 180 minutes after the start of the cold exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.