Central nervous effects of exendin-4 on hunger and satiety in obesity and diabetes mellitus type 2: an fMRI study - Neuroimaging and Obesity

Conditions: Obesity (N=20) vs. obesity with type 2 diabetes (N=20)
Randomised + controlled + cross-over + prospective + double-blind + stratified + 2 arms:Exendin-4 vs NaCl 0.9% iv ober 100 minutes on two separate study days during event-related functional magnetic resonance imaging in hungry (fasted) and fed state (after ad libitum meal.
MedDRA version: 9.1Level: LLTClassification code 10029885Term: Obesity, unspecified
MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

Registration Number: EUCTR2007-007970-47-DE

Lead Sponsor: niversity of Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

All subjects:
- male
- age 18-45 years
- BMI =30 kg/m²
- non vegetarians
- right handedness
- informed consent
- normal/ corrected to normal vision
- German native speaker
Subjects with typ2 diabetes mellitus:
- antidiabetic medicatio: metformin or sulfonylureas
- duration od diabetes = 2 years
- HbA1c > 6.5%
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with T2D:
- anti.diabetes drugs other than sulfonylureas or metformin

All subjects:
- female
- eating disorders
- chronic diseases, other than T2D, hyperlipidemia or hypertension
- chronic kidney failure = 2 KDOQI
- mental disease or retardation with impaired jugdement power
- epilepsia
- claustrophobia
- alcohol addiction
- endocrine diseases
- flu-like symptoms in the previous 2 weeks
- no informed consent
- metallic implants/devices, e. g. pace maker
- participation in another interventional trial or trial liable to insurance deductions
- contraindications for study medication (e.g. hypersensitivity to ingredients- e.g. metacresol/ contraindications according SmpC/ against albumin/ plasma proteins)
- non-compliance
- medical therapy (especially for weight control): except antihypertensive drugs/ lipid lowering drugs