Hormonal Regulation of Body Weight Maintenance
Status
Conditions
Treatments
Details and patient eligibility
About
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- BMI > 27 kg/m2 (adults)
Exclusion criteria
-
weight loss of more than 5kg in the last 2 months
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pregnancy, breastfeeding
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patients with:
- severe heart failure
- impaired hepatic or renal function
- anaemia
- disturbed coagulation (biopsies will not be taken in those subjects)
- infection, malabsorption
- severe hypertension
- cancer within the last 5 years
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- any other endocrine disorder
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changes of smoking habits or diets within the last 3 months prior to study inclusion
Trial design
Primary purpose
Allocation
Interventional model
Masking
286 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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