Obesity with BMI = 30kg/m²
Conditions
Interventions
Trade Name: Bromocriptin ratiopharm 2,5mg tablets
Pharmaceutical Form: Capsule
INN or Proposed INN: BROMOCRIPTINE
CAS Number: 25614-03-3
Current Sponsor code: Bromocriptinmesilat
Concentration unit: m
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. BMI = 30 kg/m2 2. Age = 18 years 3. Existence of written informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Known intolerance to bromocriptine or other components oft he IMP 2. Diabetes mellitus type 1 and type 2 (excluded by measurement of HbA1c at the screening visit, exclusion with HbA1c > 6,5%) 3. Hypo- or hyperthyroidism (excluded by measurement of TSH, fT3 and fT4) 4. Pregnancy or lactation 5. Known uncontrolled arterial hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 95mmHg; both under antihypertensive treatment) 6. Known coronary heart disease 7. Known peripheral artery occlusive disease (PAOD) 8. Known existence of one of the following hepatic diseases: acute or chronic viral hepatitis, cirrhosis oft he liver 9. Known existence of renal insufficiency, according to a glomerular filtration rate (GFR) = 59 ml/min (calculation according to the MDRD formula) 10. Known existence of Parkinson’s Disease 11. Known existence or history of one of the following psychiatric diseases: major depression, mania, anxiety disorder, obsessive compulsive disorder, schizophrenia, psychosis, addiction 12. Known existence of the following pituitary diseases: hormone secreting microadenoma of the pituitary, pituitary macroadenoma, hypophysitis 13. Treatment with bromocritine in the past 12 month 14. Known existence of a neurodegenerative disorder 15. Known existence of a gastric or intestinal ulcer 16. Known existence of a malignant disease in the past 5 years 17. Known existence of a congestive heart disease (NYHA III or IV) 18. Excess of specific thresholds of laboratory parameters listed in the study protocol 19. Comedication with drugs listed in table 5 (study protocol 4.3.2) 20. Cardiac pacemaker 21. Participation in another interventional study and intake of another investigational drug in the past 21 days 22. Persons who are in a relationship of dependency or who are employed by the sponsor or one of the investigators of the study 23. Accommodation in an institution with court order or official order 24. Non-existence of reliable contraception. Reliable contraception is defined as methods with a Pearl-Index below 1%: a. Oral hormonal contraception (“pill”) b. Dermal hormonal contraception c. Vaginal hormonal contraception (NuvaRing®) d. contraception pflaster e. Long active injectable contraception f. Progesterone-releasing implant (Implanon®) g. Tubal ligation (female sterilisation) h. Hormone-releasing intrauterine device (“coil”)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: reduction of BMI;Secondary Objective: • Change of delay discounting • change of reward behaviour (delay discounting) (FEV / questionnaire) • Change of Body composition;Primary end point(s): BMI;Timepoint(s) of evaluation of this end point: after completion of the intake of study medication at week 18. The BMI will be determined additionally in the weeks 1,2,3,4,6,9,12,15,30,42. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change of delay discounting • change of reward behaviour (delay discounting) (FEV / questionnaire) • Change of Body composition ;Timepoint(s) of evaluation of this end point: After completion of the intake of study medication at week 18. The delay discounting and the FEV will be determined additionally in the weeks 6,12,30,42. The questionnaire concerning the dietary habits will be done additionally in the weeks 1,2,3,4,6,9,12,15. Body composition will be determined additonally in the weeks 6 and 12. | — |
Countries
Germany
Contacts
Public ContactDr. Michael Faust
University of Cologne
Outcome results
None listed