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Clinical Trials/EUCTR2011-005628-16-DE
EUCTR2011-005628-16-DE
Active, not recruiting
Not Applicable

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

niversity of Cologne0 sitesMay 8, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity with BMI = 30kg/m²
Sponsor
niversity of Cologne
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Cologne

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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