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| Name | Class |
|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
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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.
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:
Each metabolic visit will last 9 hours with:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | without T2D according to Diabetes Canada diagnostics criteria: |
|
| group with Type 2 diabetes | Experimental | with T2D according to Diabetes Canada diagnostics criteria: |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Laparoscopic Sleeve Gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma NEFA flux | calculated from i.v. stable isotope tracer (mass spectrometry). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédérique Frisch | Contact | 1-819-346-1110 | 12394 | frederique.frisch@usherbrooke.ca |
| Name | Affiliation | Role |
|---|---|---|
| André Carpentier, MD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| centre de recherche du CHUS | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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.
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| Nicotinic Acid | Drug | Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested. |
|
|
magnetic resonance imaging (MRI)
| measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0) |
| Change in insulin secretion | Determined by measuring C-peptide kinetics following the liquid meal | 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 by using indirect calorimetry | 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) | WAT biopsy | measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0) |
| Change in hormonal response | Multiplex assay | measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0) |
| Change in insulin resistance /sensitivity | Determined by measuring circulating glucose, NEFA and insulin following the liquid meal | measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0) |
| Change in histology of white adipose tissue (WAT) | WAT biopsy | measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0) |
| Change in metabolite response | Colorimetric assay | measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0 |
| Change in plasma distribution of DFA metabolites (WAT DFA spillover) | calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA. | measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0) |
| Change in glycerol turnover | calculated from [1,1,2,3,3-2H]-glycerol i.v. | measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0) |
| D004700 | Endocrine System Diseases |
| D009539 |
| Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |