Obesity (N=20) vs. obesity with type 2 diabetes (N=20)
Conditions
Interventions
Trade Name: Byetta (Exenatide)
Product Name: Byetta
Product Code: AC2993
Pharmaceutical Form: Solution for infusion
CAS Number: 141758749
Other descriptive name: EXENATIDE
Concentration unit: mg/ml mi
Sponsors
University of Leipzig
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that exendin-4 alters neuronal activity in brain areas controlling feeding behaviour in male obese without and obese subjects with diabetes mellitus type 2 compared to NaCl 0.9%. ;Secondary Objective: Effect of exendin-4 compared toNaCl 0.9% on - amount of meal intake after at least 14 hours fasting - brain activity in hunger and satiety related brain areas - subjective feeling of hunger, satiety, nausea, and well-being - plasma concentrations of insulin, C-peptide, proinsulin, leptin, PYY, ghrelin, exenatide, glukagon, free fatty acids, (LDL-) cholesterol and glukose preprandila and postprandial. Differences in brain morphology in obese and individuals with diabetes mellitus type 2 using voxel-based morphometry (T1-weighted MRI scan).;Primary end point(s): Primary endpoints sensu strictu do not apply for this study. Primary measure: - To determine hunger-associated brain activity in the CNS during exendin-4 administration in male volunteers obese without and with type 2 diabetes using BOLD-fMRI in the fasting and fed state. Secondary measure To determine exendin-4 effect on: - the amount of food intake (calorie intake) after hunger-inducing visual stimulation in the fasting state. - changes in insulin, blood glucose, c-peptide, proinsulin, glucagon, Exenatide, HbA1c, free fatty acids and cholesterol - feelings of hunger and satiety after visual stimulation with food and non-food related images in the fasting state Differences in brain morphology copmaring obese sunjects with ans without type 2 diabetes. | — |
Countries
Germany
Outcome results
None listed