Recruiting

Bariatric Surgery

Sponsor:

Université de Sherbrooke

Code:

NCT05934409

Conditions

Diabetes Mellitus Type 2

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Bariatric surgery

Nicotinic Acid

Study Details

Brief 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.

Conditions

Diabetes Mellitus Type 2

Study ID

NCT05934409

Start date

Nov 1, 2023

Status verified date

Feb, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Control group

without T2D according to Diabetes Canada diagnostics criteria:

experimental: group with Type 2 diabetes

with T2D according to Diabetes Canada diagnostics criteria:

Interventions

Bariatric surgery

Laparoscopic Sleeve Gastrectomy

Nicotinic Acid

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

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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Frédérique Frisch

1-819-346-1110frederique.frisch@usherbrooke.ca

Locations

centre de recherche du CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Frederique Frisch

8193461110frederique.frisch@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Bariatric surgery
  • remission from Type 2 diabetes
  • PET imaging
  • adipose tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-02-10.