FTO-genotype dependent weight reduction under treatment with bromocriptin in obesity

• Conditions: Obesity with BMI = 30kg/m²; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005628-16-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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”)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: reduction of BMI;Secondary Objective: •Change of delay discounting<br>•change of reward behaviour (delay discounting) (FEV / questionnaire)<br>•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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Change of delay discounting<br>•change of reward behaviour (delay discounting) (FEV / questionnaire)<br>•Change of Body composition<br>;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.