Clinical trial
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
Name
2022-4624
Description
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.
Trial arms
Trial start
2023-11-01
Estimated PCD
2028-01-31
Trial end
2028-05-01
Status
Recruiting
Treatment
Bariatric surgery
Laparoscopic Sleeve Gastrectomy
Arms:
Control group, group with Type 2 diabetes
Nicotinic Acid
Only during A1. 150mg every half hour for 6 hours. A total dose of 1800mg will be ingested.
Arms:
Control group, group with Type 2 diabetes
Other names:
Niacin
Size
40
Primary endpoint
Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning
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
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).
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
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
measured before and after liquid meal at Baseline (A0), 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-11-28
1 organization
1 product
1 indication
Organization
Université de SherbrookeProduct
Nicotinic AcidIndication
Diabetes Mellitus Type 2