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RecruitingNCT05934409

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

Improved Adipose Tissue Storage of Dietary Fatty Acids as a New Mechanism for the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Université de Sherbrooke · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Detailed description

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: * 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

Interventions

TypeNameDescription
PROCEDUREBariatric surgeryLaparoscopic Sleeve Gastrectomy
DRUGNicotinic AcidOnly during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.

Timeline

Start date
2023-11-01
Primary completion
2028-01-31
Completion
2028-05-01
First posted
2023-07-07
Last updated
2026-02-10

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05934409. Inclusion in this directory is not an endorsement.