diabetes Insulin resistance
Conditions
Interventions
Bromocriptine (DA D2 receptor agonist) orally once daily (
Sponsors
Amsterdam UMC, locatie AMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Overweight/obese (BMI>25.0 kg/m2) T2DM patient, treated with oral glucose lowering medication (except for DDP4-inhibitors). - Age 50-70 years - Males and postmenopausal females: (history, amenorrhoea, elevated FSH) - Stable weight (
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - any current somatic (except for stable obesity- or T2DM-related comorbidities) or psychiatric disorder; - shift work - uncontrolled hypertension - the use of excessive alcohol or recreational drugs - smoking - any use of medication (including NSAIDs) except for lipid lowering, blood pressure lowering drugs and occasional use of paracetamol (less frequent than 2 days a week) - history of psychiatric disorder or drug- or alcohol abuse - history of cerebro- and/or cardiovascular diseases - history of the use of dexamphetamine or dopamine agonists - abnormal ECG at rest or during the exercise stress test - positive family history of sudden death - childhood-onset obesity - history of bariatric surgery - allergy or hypersensitivity to ergot alkaloids - allergy or hypersensitivity to sympathomimetic amines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of the bromocriptine intervention on i. dexamphetamine-stimulated dopamine release (SPECT imaging; * D2/3R BPND), and ii. insulin sensitivity of adipose tissue, liver and skeletal muscle (hyperinsulinemic, euglycemic clamp; percentage of insulin-induced suppression of free fatty acids (FFA) and endogenous glucose production (EGP), and insulin-stimulated rate of disappearance, respectively). Furthermore, we aim to assess the correlation between bromocriptine-induced changes in stimulated dopamine release and changes in insulin sensitivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary parameters will be assessed in all subjects before and after the bromocriptine intervention: - Neuropsychological functioning and feeding behaviour characteristics assessed by questionnaires and tasks - Dexamphetamine-induced changes in feelings of appetite and satiety measured with VAS scores, the G-FCQ-S questionnaire and a test meal (quantity of food consumed) - Resting energy expenditure - Body composition | — |
Countries
Netherlands
Outcome results
None listed