Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery (CB5)

February 9, 2026 updated by: André Carpentier, Université de Sherbrooke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
without T2D according to Diabetes Canada diagnostics criteria:
Procedure: Bariatric surgery
Laparoscopic Sleeve Gastrectomy
Drug: Nicotinic Acid
Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.
Other Names:
  • Niacin
Experimental: group with Type 2 diabetes
with T2D according to Diabetes Canada diagnostics criteria:
Procedure: Bariatric surgery
Laparoscopic Sleeve Gastrectomy
Drug: Nicotinic Acid
Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.
Other Names:
  • Niacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
[18F]-FTHA PET
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).
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
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
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
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
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
measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
calculated from i.v. stable isotope tracer (mass spectrometry).
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)
magnetic resonance imaging (MRI)
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)
Determined by measuring C-peptide kinetics following the liquid meal
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)
measured by using indirect calorimetry
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)
WAT biopsy
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)
Multiplex assay
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)
Determined by measuring circulating glucose, NEFA and insulin following the liquid meal
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)
WAT biopsy
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
Colorimetric assay
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)
calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.
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)
calculated from [1,1,2,3,3-2H]-glycerol i.v.
measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Investigators

  • Principal Investigator: André Carpentier, MD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-4624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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