Diabetes Mellitus Type 2CB5NCT05934409
Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
A study testing Bariatric surgery and Nicotinic Acid in people with Diabetes Mellitus Type 2, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The present protocol aims to understand and establish whether there is a causal link between adipose tissue metabolic remodeling and Type 2 Diabetes (T2D) remission after bariatric surgery. All participants will have a bariatric surgery, divided in 2 groups: with or without T2D. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Bariatric surgery and Nicotinic Acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 65
- BMI 35 kg/m2
- Diagnosed T2D - according to Diabetes Canada diagnostics criteria.
- Diagnosed non-T2D - according to Diabetes Canada diagnostics criteria.
- Women with a negative serum pregnancy test.
Who cannot join
- Treatment with an oral contraceptive;
- Treatment with fibrate, thiazolidinedione, insulin, or beta-blocker, drugs that affect metabolism and cannot be stopped temporarily or which have long-lasting effects;
- Presence of overt cardiovascular disease, liver or renal failure or other uncontrolled medical conditions;
- Any other contraindication to surgery or to temporarily suspending current medications for diabetes, lipids or hypertension;
- Smoking or consumption of more than 2 alcoholic beverages per day;
- Any contraindication to MRI;
Show all 11Show fewer
- A Diabetes Remission (DiaRem) score >8 (low probability of T2D remission);
- Having participated to a research study with exposure to radiation in the last two years before the start of the study;
- Pregnant or breastfeeding women;
- Patients weighing more than 200 kg to respect the weight and gantry limit of our MRI and PET/CT scanners.
- Being allergic to eggs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
Frederique Frisch, 8193461110, frederique.frisch@usherbrooke.ca
About this study
Official title: Improved Adipose Tissue Storage of Dietary Fatty Acids as a New Mechanism for the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
The present protocol aims to understand and establish whether there is a causal link between adipose tissue metabolic remodeling and Type 2 Diabetes (T2D) remission after bariatric surgery.
All participants will have a bariatric surgery, divided in 2 groups: with or without T2D.
Read the detailed description
This clinical assay will include 5 visits: the screening visit and four 9-hour postprandial metabolic sessions (A0, A1, B0 and C0) before and after surgery:
- initial visit: screening
- before surgery: 2 metabolic sessions A0 and A1 (without/with niacin) will be performed, in random order, at least one week interval.
- 12 days post surgery: 1 metabolic session B0 (without niacin)
- 1 year post surgery: 1 metabolic session C0 (without niacin)
Each metabolic visit will last 9 hours with:
- perfusion of stable tracers,
- ingestion of a liquid meal
- Positron-Emitting-Tomography (PET) acquisitions using radiopharmaceuticals such as [18F]-fluoro-6-thia-heptadecanoic acid ([18F]-FTHA) and [11C]-palmitate,
- MRI acquisitions.[18F]fluoro-6-thia-heptadecanoic acid (FTHA).
The niacin will be given during metabolic visits A1 as a regulator of lipids metabolism. During these visits, the subjects will ingest 150mg every half hour for 6 hours. Niacin will be used as a pharmacological suppressor of dietary fatty acid (DFA) spillover in order to determine the role played by this mechanism in the reduction of postprandial endogen glucose production (EGP) in T2D after bariatric surgery.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Bariatric surgery, Nicotinic Acid
- Keywords
- Bariatric surgery, remission from Type 2 diabetes, PET imaging, adipose tissue
- 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.
Bariatric surgeryProcedure or surgery
Laparoscopic Sleeve Gastrectomy
Nicotinic AcidDrug
Also called Niacin
Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | without T2D according to Diabetes Canada diagnostics criteria: Receives: Procedure: Bariatric surgery; Drug: Nicotinic Acid |
| group with Type 2 diabetes | Experimental | with T2D according to Diabetes Canada diagnostics criteria: Receives: Procedure: Bariatric surgery; Drug: Nicotinic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning
[18F]-FTHA PET
Measured: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in lean organ (liver, heart and muscle) DFA uptake and partitioning
[18F]-FTHA PET
Measured: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in liver non-esterified fatty acid (NEFA) uptake, oxidation, esterification and secretion into very low-density lipoprotein (VLDL).
calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics
Measured: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in Endogenous Glucose production and meal glucose systemic flux
i.v. and oral stable isotope tracer
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in cardiac non-esterified fatty acid (NEFA) uptake, oxidation and esterification
calculated from the same multicompartmental equation using cardiac [11C]-palmitate kinetics
Measured: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Secondary outcomes (11)
Change in plasma NEFA flux
calculated from i.v. stable isotope tracer (mass spectrometry).
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in hepatic Triglyceride (TG) content
magnetic resonance imaging (MRI)
Measured: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in insulin secretion
Determined by measuring C-peptide kinetics following the liquid meal
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in total substrate utilisation
measured by using indirect calorimetry
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in gene and protein expression of white adipose tissue (WAT)
WAT biopsy
Measured: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in hormonal response
Multiplex assay
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in insulin resistance /sensitivity
Determined by measuring circulating glucose, NEFA and insulin following the liquid meal
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in histology of white adipose tissue (WAT)
WAT biopsy
Measured: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in metabolite response
Colorimetric assay
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0
Change in plasma distribution of DFA metabolites (WAT DFA spillover)
calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in glycerol turnover
calculated from [1,1,2,3,3-2H]-glycerol i.v.
Measured: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Nov 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It will be a randomized crossover study prior to bariatric surgery (visits A0 and A1) followed by a longitudinal follow-up study after surgery (visits B0 and C0) in two groups (type 2 diabetes vs. controls). Inside each group, the protocol will be carried out as a within-subject, in which each subject will serve as his/her own control.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André Carpentier, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934409
- Sponsor's protocol ID
- 2022-4624
- Acronym
- CB5
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2023
- Last updated
- 10 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Adipose Tissue Storage of Dietary Fatty Acids as a New Mechanism for the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05934409
- Acronym / sponsor ID
- CB5 / 2022-4624
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Bariatric surgery, remission from Type 2 diabetes, PET imaging, adipose tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Jul 2023 (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.
The present protocol aims to understand and establish whether there is a causal link between adipose tissue metabolic remodeling and Type 2 Diabetes (T2D) remission after bariatric surgery.
All participants will have a bariatric surgery, divided in 2 groups: with or without T2D.
Detailed description
This clinical assay will include 5 visits: the screening visit and four 9-hour postprandial metabolic sessions (A0, A1, B0 and C0) before and after surgery:
- initial visit: screening
- before surgery: 2 metabolic sessions A0 and A1 (without/with niacin) will be performed, in random order, at least one week interval.
- 12 days post surgery: 1 metabolic session B0 (without niacin)
- 1 year post surgery: 1 metabolic session C0 (without niacin)
Each metabolic visit will last 9 hours with:
- perfusion of stable tracers,
- ingestion of a liquid meal
- Positron-Emitting-Tomography (PET) acquisitions using radiopharmaceuticals such as [18F]-fluoro-6-thia-heptadecanoic acid ([18F]-FTHA) and [11C]-palmitate,
- MRI acquisitions.[18F]fluoro-6-thia-heptadecanoic acid (FTHA).
The niacin will be given during metabolic visits A1 as a regulator of lipids metabolism. During these visits, the subjects will ingest 150mg every half hour for 6 hours. Niacin will be used as a pharmacological suppressor of dietary fatty acid (DFA) spillover in order to determine the role played by this mechanism in the reduction of postprandial endogen glucose production (EGP) in T2D after bariatric surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be a randomized crossover study prior to bariatric surgery (visits A0 and A1) followed by a longitudinal follow-up study after surgery (visits B0 and C0) in two groups (type 2 diabetes vs. controls). Inside each group, the protocol will be carried out as a within-subject, in which each subject will serve as his/her own control.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Bariatric surgery, Drug: Nicotinic Acidwithout T2D according to Diabetes Canada diagnostics criteria: |
| group with Type 2 diabetes | Experimental | Procedure: Bariatric surgery, Drug: Nicotinic Acidwith T2D according to Diabetes Canada diagnostics criteria: |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 65
- BMI 35 kg/m2
- Diagnosed T2D - according to Diabetes Canada diagnostics criteria.
- Diagnosed non-T2D - according to Diabetes Canada diagnostics criteria.
- Women with a negative serum pregnancy test.
Key exclusion criteria (11 listed)
- Treatment with an oral contraceptive;
- Treatment with fibrate, thiazolidinedione, insulin, or beta-blocker, drugs that affect metabolism and cannot be stopped temporarily or which have long-lasting effects;
- Presence of overt cardiovascular disease, liver or renal failure or other uncontrolled medical conditions;
- Any other contraindication to surgery or to temporarily suspending current medications for diabetes, lipids or hypertension;
- Smoking or consumption of more than 2 alcoholic beverages per day;
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 |
|---|---|---|
| Bariatric surgeryLaparoscopic Sleeve Gastrectomy | Procedure or surgery | Control group, group with Type 2 diabetes |
| Nicotinic AcidAlso: NiacinOnly during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested. | Drug | Control group, group with Type 2 diabetes |
Primary outcome
Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning
Time frame: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
[18F]-FTHA PET
Change in lean organ (liver, heart and muscle) DFA uptake and partitioning
Time frame: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
[18F]-FTHA PET
Change in liver non-esterified fatty acid (NEFA) uptake, oxidation, esterification and secretion into very low-density lipoprotein (VLDL).
Time frame: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics
Change in Endogenous Glucose production and meal glucose systemic flux
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
i.v. and oral stable isotope tracer
Change in cardiac non-esterified fatty acid (NEFA) uptake, oxidation and esterification
Time frame: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
calculated from the same multicompartmental equation using cardiac [11C]-palmitate kinetics
11 secondary outcomes
Change in plasma NEFA flux
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in hepatic Triglyceride (TG) content
Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in insulin secretion
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in total substrate utilisation
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in gene and protein expression of white adipose tissue (WAT)
Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in hormonal response
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in insulin resistance /sensitivity
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in histology of white adipose tissue (WAT)
Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
Change in metabolite response
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0
Change in plasma distribution of DFA metabolites (WAT DFA spillover)
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Change in glycerol turnover
Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
André Carpentier, MD 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 Bariatric surgery and Nicotinic Acid in people with Diabetes Mellitus Type 2, 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédérique Frisch (1-819-346-1110 ext. 12394, frederique.frisch@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning (time frame: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)). The study lists 5 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 10 Feb 2026.