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Brown Fat Activation Treatments for Type 2 Diabetes (GB8 Trial)
N/A
Recruiting
Led By André Carpentier
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
10 men and 10 women with T2D.
Be older than 18 years old
Must not have
Presence of overt cardiovascular, liver, renal or other medical conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Awards & highlights
Summary
This trial will use a new method to more accurately measure the activity of brown fat, which could help to better understand how to use it to treat obesity.
Who is the study for?
This trial is for 20 individuals with Type 2 Diabetes (T2D) and 20 non-diabetic individuals, both groups balanced in terms of sex, body mass index (BMI), and age. Participants should not have serious heart, liver or kidney conditions, be on certain diabetes or lipid-altering medications except for some like statins or metformin, smoke heavily, drink more than two alcoholic beverages daily, have had radiation exposure from research within the last two years, have MRI contraindications or significant weight/lifestyle changes recently.
What is being tested?
The study tests how brown adipose tissue (BAT) metabolism can be activated in people with T2D using cold exposure and oral Nicotinic acid. It will use advanced imaging techniques like PET/CT scans with a new tracer C11-palmitate to measure BAT activity more accurately compared to traditional methods.
What are the potential side effects?
Potential side effects may include discomfort from cold exposure and reactions to Nicotinic acid such as skin flushing or gastrointestinal issues. The imaging procedures might involve risks related to radiation exposure and the contrast agents used during scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am one of 10 men or 10 women diagnosed with type 2 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious heart, liver, kidney, or other medical condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BAT volume
Brown Adipose Tissue (BAT) Glucose uptake
Secondary study objectives
Activation of BAT (oxidative metabolism)
Triglycerides
Insulin
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Subject without type 2 Diabetes- cold exposure and nicotinic acidExperimental Treatment2 Interventions
3-hour cold exposure with oral nicotinic acid: Protocol A
Group II: Subject with type 2 Diabetes- cold exposure and nicotinic acidExperimental Treatment2 Interventions
3-hour cold exposure with oral nicotinic acid: Protocol A
Group III: Subject without Type 2 Diabetes- cold exposureActive Control1 Intervention
3-hour cold exposure: Protocol B
Group IV: Subject with Type 2 Diabetes- cold exposureActive Control1 Intervention
3-hour cold exposure: Protocol B
Find a Location
Who is running the clinical trial?
Université de SherbrookeLead Sponsor
302 Previous Clinical Trials
70,223 Total Patients Enrolled
André CarpentierPrincipal InvestigatorUniversité de Sherbrooke
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a non-diabetic person matched in sex, BMI, and age with a Type 2 diabetes participant.You have been in another research study involving radiation in the past two years.You have a medical reason that makes it unsafe for you to have an MRI scan.I am a man/woman with type 2 diabetes.I am a non-diabetic person matched in sex, BMI, and age with a Type 2 diabetes participant.I have a serious heart, liver, kidney, or other medical condition.You have gained or lost more than 2 kilograms in the past 3 months, or you have recently made big changes to your lifestyle.I am not currently taking certain medications that affect my cholesterol or blood sugar, except for some allowed ones.I cannot stop my current medications for cholesterol or high blood pressure.I am one of 10 men or 10 women diagnosed with type 2 diabetes.You smoke or drink more than 2 alcoholic drinks per day.
Research Study Groups:
This trial has the following groups:- Group 1: Subject without Type 2 Diabetes- cold exposure
- Group 2: Subject without type 2 Diabetes- cold exposure and nicotinic acid
- Group 3: Subject with Type 2 Diabetes- cold exposure
- Group 4: Subject with type 2 Diabetes- cold exposure and nicotinic acid
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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