RecruitingNot Applicable

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

Canada40 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning

Timeframe: 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

Timeframe: 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).

Timeframe: 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

Timeframe: 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

Timeframe: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)

Trial details

NCT IDNCT05934409

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Frédérique Frisch

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

View on ClinicalTrials.gov More Diabetes Mellitus Type 2 trials