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NCT Number: NCT05934409

Adipose Tissue Storage in 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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location status: Recruiting

Location contact

Frederique Frisch

CONTACT

[email protected]

8193461110

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Laparoscopic Sleeve Gastrectomy

Nicotinic acid

Drug

Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.

Other names: Niacin

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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).

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frédérique Frisch

CONTACT

[email protected]

1-819-346-1110 ext. 12394

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study 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

Acronym: CB5

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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