De effects of the bloodglucose lowering drugs exenatide (GLP-1 receptor agonist) and dapagliflozine ( a SGLT2 inhibitor) on the brain, food intake and bodyweight.
- Conditions
- Type 2 diabetes mellitusObesityTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-000841-28-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Age 18-65 years
- BMI 30–40 kg/m2
- Stable bodyweight (<5% reported change during the previous 3 months).
- Diagnosed with T2DM > 3 months prior to screening
- HbA1C 7.5–10%
- Treatment with metformin and/or sulphonylurea at a stable dose for at least 3 months.
- Right handed
- Both genders; for women: post menopausal (excluding possible menstruation cycle effects)
- Caucasian
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 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- GLP-1 based therapies, DPP-4 inhibitors, thiazolidinediones or insulin within 3 months before screening
- Weight-lowering agents within 3 months before screening.
- Congestive heart failure (NYHA II-IV)
- Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))
- Liver disease
- History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
- Patients with MEN2 syndrome or history or family history of medullary thyroid carcinoma
- Neurological illness
- Malignancy (except for basal cell carcinoma)
- History of major heart disease
- History of major renal disease
- Pregnancy or breast feeding
- Implantable devices
- Substance abuse
- Addiction
- Alcohol abuse (defined as: for men > 21 units/week, for women >14 units/week)
- Smoking/ nicotine abuse (defined as: daily smoking / a daily use of nicotine)
- Contra-indication for MRI, such as claustrophobia or pacemaker
- Any psychiatric illness; including eating disorders and depression
- Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
- Use of cytostatic or immune modulatory agents
- History of allergy for exenatide or other GLP-1 RA
- Participation in other studies at time of the screening visit
- Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method