Health TrialsbyHealthPanel

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

ConditionDiabetes Mellitus Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bariatric surgery

    Procedure/Surgery

    Laparoscopic Sleeve Gastrectomy

  • Nicotinic Acid

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 2 interventions
Group B: group with Type 2 diabetesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

\[18F\]-FTHA PET

Time frame
measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
2

Change in lean organ (liver, heart and muscle) DFA uptake and partitioning

\[18F\]-FTHA PET

Time frame
measured after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
3

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

Time frame
measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
4

Change in Endogenous Glucose production and meal glucose systemic flux

i.v. and oral stable isotope tracer

Time frame
measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)

Secondary outcomes

1

Change in plasma NEFA flux

calculated from i.v. stable isotope tracer (mass spectrometry).

Time frame
measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
2

Change in hepatic Triglyceride (TG) content

magnetic resonance imaging (MRI)

Time frame
measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)
3

Change in insulin secretion

Determined by measuring C-peptide kinetics following the liquid meal

Time frame
measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)
4

Change in total substrate utilisation

measured by using indirect calorimetry

Time frame
measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Source ClinicalTrials.gov
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