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Beta-2 Adrenergic Receptor Agonist
Formoterol Fumarate for Type 2 Diabetes and Obesity (GB10 Trial)
N/A
Waitlist Available
Led By André C. Carpentier, M.D.
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 60 minutes before and 90 minutes after cold exposure (a) and 30 minutes after inhalation of fumarate formoterol (b and c)
Awards & highlights
GB10 Trial Summary
This trial is testing if a drug called formoterol fumarate can help people with obesity and Type 2 diabetes by activating their brown adipose tissue.
Eligible Conditions
- Obesity
- Type 2 Diabetes
GB10 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured 60 minutes before and 90 minutes after cold exposure (a) and 30 minutes after inhalation of fumarate formoterol (b and c)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 60 minutes before and 90 minutes after cold exposure (a) and 30 minutes after inhalation of fumarate formoterol (b and c)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brown Adipose Tissue thermogenesis (formoterol induced, cold-induced and effect of nicotinic acid)
Secondary outcome measures
BAT triglyceride content
Brown Adipose Tissue (BAT) glucose uptake
Nonesterified Fatty Acids
+7 moreGB10 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Formoterol without nicotinic acidExperimental Treatment5 Interventions
Formoterol fumarate or Oxeze® Turbuhaler®: 48 µg (4 inhalations of 12 µg).
Group II: Formoterol with nicotinic acidExperimental Treatment6 Interventions
Formoterol fumarate or Oxeze® Turbuhaler®: 48 µg (4 inhalations of 12 µg).
Nicotinic acid or Niacin: repeated doses of 150 MG every 30 minutes, for 3 hours.
Group III: Acute Cold ExposureActive Control7 Interventions
3h-acute cold exposure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iv lines
2022
N/A
~20
Formoterol Fumarate 12 micrograms Inhalation Powder
2022
N/A
~20
Nicotinic Acid 50 MG Oral Tablet
2022
N/A
~20
Positron Emission Tomography (PET)
2018
Completed Phase 4
~1390
Indirect calorimetry
2015
Completed Phase 4
~870
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Université de SherbrookeLead Sponsor
298 Previous Clinical Trials
69,929 Total Patients Enrolled
14 Trials studying Obesity
2,673 Patients Enrolled for Obesity
André C. Carpentier, M.D.Principal InvestigatorUniversité de Sherbrooke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke or drink more than two alcoholic beverages per day.You have a long-term medical condition that requires medication.You cannot have taken any medication other than acetaminophen or non-steroidal anti-inflammatory drugs without decongestants or stimulants, within a short period of time.You are taking any medication regularly, except for birth control pills.You have had an allergic reaction or intolerance to lactose, formoterol, nicotinic acid, or local anesthesia in the past.Your body mass index (BMI) falls between 18 and 30 kg/m2.You have gained or lost more than 2 kilograms of weight in the last three months, or made significant changes to your lifestyle.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Cold Exposure
- Group 2: Formoterol with nicotinic acid
- Group 3: Formoterol without nicotinic acid
Awards:
This trial has 1 awards, including:- 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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