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Recruiting NCT05934409

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

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric surgery, Nicotinic Acid.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Bariatric surgery
    Laparoscopic Sleeve Gastrectomy
  • Drug Nicotinic Acid
    Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.

Primary outcome measures

  • Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning [Time frame: 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 [Time frame: 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). [Time frame: 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 [Time frame: 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 [Time frame: measured before and after liquid meal at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)]
Secondary outcome measures (11)
  • Change in plasma NEFA flux [Time frame: 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 [Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)]
  • Change in insulin secretion [Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)]
  • Change in total substrate utilisation [Time frame: 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) [Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)]
  • Change in hormonal response [Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)]
  • Change in insulin resistance /sensitivity [Time frame: 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) [Time frame: measured at Baseline (A0), at Day 12 (B0) and at Week 52 (C0)]
  • Change in metabolite response [Time frame: 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) [Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)]
  • Change in glycerol turnover [Time frame: measured before and after liquid meal at Baseline (A0 +A1), at Day 12 (B0) and at Week 52 (C0)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • centre de recherche du CHUS — Sherbrooke

Identifiers

NCT: NCT05934409 · 2022-4624

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗