Brown Adipose Tissue Metabolism in Type 2 Diabetes

NCT05092945 | Completed

• 1 other identifier: 2019-2990
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• BAT volume

  Assessed using i.v. injection of 18FDG with whole-body PET/CT acquisition.

  180 minutes after the start of the cold exposure

• 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 Outcomes (7)

• Activation of BAT (oxidative metabolism)

  90 minutes after beginning cold exposure

• Fatty Acid uptake and metabolism

  at baseline and at time 120 minutes after beginning cold exposure

• BAT triglyceride content

  at baseline and at time 180 (for CT) and 240 (for MR) after cold exposure.

• Whole-body lipolysis

  -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.

• Hepatic Glucose production

  -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.

Study Arms (4)

Subject with Type 2 Diabetes- cold exposure

ACTIVE COMPARATOR

3-hour cold exposure: Protocol B

Other: Cold exposure

Subject with type 2 Diabetes- cold exposure and nicotinic acid

EXPERIMENTAL

3-hour cold exposure with oral nicotinic acid: Protocol A

Other: Cold exposure; Drug: Oral Nicotinic acid

Subject without Type 2 Diabetes- cold exposure

ACTIVE COMPARATOR

3-hour cold exposure: Protocol B

Other: Cold exposure

Subject without type 2 Diabetes- cold exposure and nicotinic acid

EXPERIMENTAL

3-hour cold exposure with oral nicotinic acid: Protocol A

Other: Cold exposure; Drug: Oral Nicotinic acid

Interventions

Cold exposure OTHER

The liquid-conditioned tube suit will be perfused with 18°C water using a temperature- and flow-controlled circulation bath from time 0 to 180 min.

Subject with Type 2 Diabetes- cold exposure; Subject with type 2 Diabetes- cold exposure and nicotinic acid; Subject without Type 2 Diabetes- cold exposure; Subject without type 2 Diabetes- cold exposure and nicotinic acid

Oral Nicotinic acid DRUG

A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg: one dose of 150 mg at time 0 and 60 minutes, one dose of 100 mg at time 120 minutes and 180 minutes.

Also known as: Niacin 500 (Jamp Pharma) NPN 00557412

Subject with type 2 Diabetes- cold exposure and nicotinic acid; Subject without type 2 Diabetes- cold exposure and nicotinic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and 10 women with T2D.
• non-diabetic men and 10 non-diabetic women (matched for sex, BMI and age to the T2D participants).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Niacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• André Carpentier

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: tenured professor

Model Details: Two groups in parallel (with and without Type 2 diabetes). In each group, the protocol will be carried out as a within-subject, randomized, cross-over study in which each subject will serve as his/her own control.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: October 26, 2021
• Study Start: May 18, 2021
• Primary Completion: February 10, 2022
• Study Completion: August 18, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CA (1)