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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
Awards & highlights

GB8 Trial 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.Check my eligibility
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.See study design
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.

GB8 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am one of 10 men or 10 women diagnosed with type 2 diabetes.

GB8 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and -150 and 0 minutes before and 60, 120 and 180 minutes after cold exposure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BAT volume
Brown Adipose Tissue (BAT) Glucose uptake
Secondary outcome measures
Activation of BAT (oxidative metabolism)
Triglycerides
Insulin
+4 more

GB8 Trial 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
292 Previous Clinical Trials
69,401 Total Patients Enrolled
André CarpentierPrincipal InvestigatorUniversité de Sherbrooke
2 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Cold exposure (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05092945 — N/A
Type 2 Diabetes Research Study Groups: Subject without Type 2 Diabetes- cold exposure, Subject without type 2 Diabetes- cold exposure and nicotinic acid, Subject with Type 2 Diabetes- cold exposure, Subject with type 2 Diabetes- cold exposure and nicotinic acid
Type 2 Diabetes Clinical Trial 2023: Cold exposure Highlights & Side Effects. Trial Name: NCT05092945 — N/A
Cold exposure (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a cut-off age for participants in this scientific exploration?

"To qualify for this clinical trial, potential participants must be aged 18-65. On the other hand, there are 193 trials targeting minors and 1113 specifically designed to aid patients over 65 years old."

Answered by AI

Can individuals currently enroll in this clinical trial?

"Indeed, clinicaltrials.gov information confirms that this medical study has been posted since May 18th 2021 and is actively recruiting patients. 40 participants are needed for the trial which will be conducted at 1 site."

Answered by AI

What is the intention of this clinical investigation?

"The primary measurement for this trial, taken at 150 minutes post cold exposure, is BAT volume. Secondary metrics include hepatic glucose production (determined by perfusion of tritiated-glucose), triglyceride content in BAT (estimated via MRI scans on a 3T clinical system) and substrate utilisation (calculated through VO2/VCO2 measurements)."

Answered by AI

What kind of person is the ideal candidate for participating in this clinical research?

"This medical research seeks to enrol 40 individuals with type 2 diabetes mellitus, aged from 18-65 years old. The study additionally requires 20 non-diabetic persons (10 men and 10 women), matched for sex, BMI, and age to the diabetic cohort of participants."

Answered by AI

What therapeutic benefits have been observed from Cold exposure?

"Cold exposure is a well-known treatment for high cardiovascular risk, as it can effectively regulate other health issues such as dyslipidemias, pancreatitis risks, and lipidemia."

Answered by AI

What is the maximum number of participants accepted in this clinical investigation?

"Yes, the information posted on clinicaltrials.gov denotes that this experiment is actively seeking participants - it was first uploaded on May 18th 2021 and updated most recently on October 12th 2021. 40 individuals are required to be enrolled from a single medical facility."

Answered by AI

Who else is applying?

What site did they apply to?
Centre de recherche du CHUS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Brown Adipose Tissue Metabolism in Type 2 Diabetes
André Carpentier 2021. "Brown Adipose Tissue Metabolism in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092945.
~7 spots leftby Dec 2024
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