Effect of Exenatide on brown adipose tissue

The effect of Exenatide on brown adipose tissue activity and energy expenditure in healthy young men - ExeBAT study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000238-23-NL

Enrollment

Registered

2016-07-28

Start date

2016-08-09

Completion date

Unknown

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers, intended indications: obesity and dyslipidemia

Interventions

Trade Name: Bydureon Product Name: Exenatide (Bydureon) Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled pen

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Dutch South Asian or white Caucasian male, 18-30 years - BMI = 18 and = 25 kg/m2 - Good general health Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - BMI > 25 kg/m2 or < 18 kg/m2 - Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g. beta blockers) - Any significant chronic disease - Renal, hepatic or endocrine disease - Smoking - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study - Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year - Contraindications for undergoing an MRI scan: - Presence of non-MR safe metal implants or objects in the body. - Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid, large recent tattoos. - Claustrophobia - Tinnitus or hyperacusis

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of Exenatide treatment on BAT activity and energy expenditure in healthy young subjects of South Asain and white Caucasian descent;Secondary Objective: To validate the MRI scan as a novel technique for measuring BAT;Primary end point(s): BAT volume and activity measured by 18F-FDG PET-CT scan and MRI scan;Timepoint(s) of evaluation of this end point: After 12 weeks of Exenatide treatment	—

Measure

Time frame

Main Objective: To evaluate the effect of Exenatide treatment on BAT activity and energy expenditure in healthy young subjects of South Asain and white Caucasian descent;Secondary Objective: To validate the MRI scan as a novel technique for measuring BAT;Primary end point(s): BAT volume and activity measured by 18F-FDG PET-CT scan and MRI scan;Timepoint(s) of evaluation of this end point: After 12 weeks of Exenatide treatment

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Secondary

Measure	Time frame
Secondary end point(s): - Fasted thermoneutral and cold-induced REE by indirect calorimetrie - Body weight and fat mass measured by BIA measurement - Fasting serum markers for glucose metabolism (glucose, insulin) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids);Timepoint(s) of evaluation of this end point: After 12 weeks of Exenatide treatment	—

Measure

Time frame

Secondary end point(s): - Fasted thermoneutral and cold-induced REE by indirect calorimetrie - Body weight and fat mass measured by BIA measurement - Fasting serum markers for glucose metabolism (glucose, insulin) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids);Timepoint(s) of evaluation of this end point: After 12 weeks of Exenatide treatment

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Countries

Netherlands

Contacts

Public ContactClinical trial information

Leiden University Medical Center

l.g.m.janssen@lumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026