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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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 below

Select...

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.

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.