Type 2 Diabetes Clinical Trial
— GB8Official title:
Quantifying Brown Adipose Tissue Thermogenesis in Type 2 Diabetes
NCT number | NCT05092945 |
Other study ID # | 2019-2990 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 18, 2021 |
Est. completion date | March 2025 |
Activation of brown adipose tissue (BAT) by cold exposure. BAT thermogenesis and BAT volume of metabolic activity will be assessed by Positron-Emitting-Tomography (PET/CT) and MRI/MRS imaging and new pharmacological methods to modulate BAT thermogenesis. All previous data on the functioning of Brown Adipose Tissue (BAT) were obtained by Positron-Emitting-Tomography (PET) imaging studies using fluorodeoxyglucose F18 ( [18F]- FDG). This approach underestimates the actual activity of the BAT. In this study, the investigator is going to use a new PET tracer (C11-palmitate) which is a fat molecule. This will allow to quantify more accurately the activity of brown fat.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 10 men and 10 women with T2D. - 10 non-diabetic men and 10 non-diabetic women (matched for sex, BMI and age to the T2D participants). Exclusion Criteria: - Change in weight of more than 2 kg over the past 3 months or recent changes in lifestyle; - Treatment with a fibrate, thiazolidinedione, insulin, beta-blocker, GLP-1 agonist, or other drug known to affect lipid or carbohydrate metabolism, except statins, metformin, sulfonylurea, DPP-IV inhibitor and other antihypertensive agents that can be temporarily stopped safely prior to the studies, as per our approved protocols; - Presence of overt cardiovascular, liver, renal or other medical conditions; - Smoking or consumption of more than 2 alcoholic beverages per day; - Any other contraindication to temporarily suspending current medications for lipids or hypertension; - Any contraindication to MRI scanning. - Having participated to a research study with exposure to radiation in the last two years before the start of the study. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BAT volume | Assessed using i.v. injection of 18FDG with whole-body PET/CT acquisition. | 180 minutes after the start of the cold exposure | |
Primary | Brown Adipose Tissue (BAT) Glucose uptake | Assessed using i.v. injection of 18FDG with sequential dynamic PET/CT scanning | 150 minutes after the start of the cold exposure | |
Secondary | Activation of BAT (oxidative metabolism) | Measured with 11C-acetate using dynamic PET/CT acquisition. | 90 minutes after beginning cold exposure | |
Secondary | Fatty Acid uptake and metabolism | Measured with 11C-palmitate using dynamic PET/CT acquisition. | at baseline and at time 120 minutes after beginning cold exposure | |
Secondary | BAT triglyceride content | Estimated by CT and MR using 1H-MRS and Dixon sequences on a 3T clinical MRI system. | at baseline and at time 180 (for CT) and 240 (for MR) after cold exposure. | |
Secondary | Whole-body lipolysis | Systemic appearance rate of glycerol and fatty acid determined by perfusion of [1,1,2,3,3-2H]-glycerol, [U-13C]-palmitate tracers and concentration of total NEFA, triglycerides, palmitate, oleate, linoleate, glycerol. | -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure. | |
Secondary | Hepatic Glucose production | Systemic appearance rate of glucose determined by perfusion of [3-3H]-glucose. | -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure. | |
Secondary | Substrate utilisation | VO2 and VCO2 will be measured by indirect calorimetry to calculate carbohydrate and fatty acid oxidation rates. | -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure. | |
Secondary | Changes in insulin level and secretion | measured with ELISA and Milliplex. | -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure. |
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