Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
NCT ID: NCT05934409
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-01
2028-05-01
Brief Summary
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All participants will have a bariatric surgery, divided in 2 groups: with or without T2D.
Detailed Description
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* initial visit: screening
* before surgery: 2 metabolic sessions A0 and A1 (without/with niacin) will be performed, in random order, at least one week interval.
* 12 days post surgery: 1 metabolic session B0 (without niacin)
* 1 year post surgery: 1 metabolic session C0 (without niacin)
Each metabolic visit will last 9 hours with:
* perfusion of stable tracers,
* ingestion of a liquid meal
* Positron-Emitting-Tomography (PET) acquisitions using radiopharmaceuticals such as \[18F\]-fluoro-6-thia-heptadecanoic acid (\[18F\]-FTHA) and \[11C\]-palmitate,
* MRI acquisitions.\[18F\]fluoro-6-thia-heptadecanoic acid (FTHA).
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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Control group
without T2D according to Diabetes Canada diagnostics criteria:
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.
group with Type 2 diabetes
with T2D according to Diabetes Canada diagnostics criteria:
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Université de Sherbrooke
OTHER
Responsible Party
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André Carpentier
Tenure professor
Principal Investigators
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André Carpentier, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Sherbrooke
Locations
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centre de recherche du CHUS
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Frederique Frisch
Role: primary
Other Identifiers
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2022-4624
Identifier Type: -
Identifier Source: org_study_id