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

NCT05934409 | Recruiting

• 1 other identifier: 2022-4624
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

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

  \[18F\]-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

  \[18F\]-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).

  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

  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

  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 Outcomes (11)

• Change in plasma NEFA flux

  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

  measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)

• Change in insulin secretion

  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 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)

  measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)

Study Arms (2)

Control group

ACTIVE COMPARATOR

without T2D according to Diabetes Canada diagnostics criteria:

Procedure: Bariatric surgery; Drug: Nicotinic Acid

group with Type 2 diabetes

EXPERIMENTAL

with T2D according to Diabetes Canada diagnostics criteria:

Procedure: Bariatric surgery; Drug: Nicotinic Acid

Interventions

Bariatric surgery PROCEDURE

Laparoscopic Sleeve Gastrectomy

Control group; group with Type 2 diabetes

Nicotinic Acid DRUG

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

Also known as: Niacin

Control group; group with Type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bariatric Surgery; Niacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• André Carpentier, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédérique Frisch

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure professor

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 7, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CA (1)