FTO-genotype dependent weight reduction under treatment with bromocriptine in obese patients

Phase 2

• Conditions: adipositas; E66.0; Obesity due to excess calories

• Registration Number: DRKS00003349
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-04
• Study Completion: 2015-06-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1.BMI = 30 kg/m2
2.Age = 18 years
3.Existence of written informed consent

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 > 100mmHg; 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the body mass index, which is calculated from the patient's weight and height according to the formula (body weight [kg] / (body height [m])²). Since the body height will be probably constant during the study, it is only determined once at the beginning of the study (first visit). The body weight will be determined weekly and later every three weeks during the study on a body scale. The body mass index will be calculated according to the formula. The difference in the body mass index between the first visit and the visit after 18 weeks represents the primary parameter.<br>