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Hormonal and Metabolic Effects of Weight Loss

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ClinicalTrials.gov Identifier: NCT00953264
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Joachim Spranger, Charite University, Berlin, Germany

Brief Summary:
The investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: lifestyle Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hormonal and Metabolic Effects of Weight Loss
Study Start Date : December 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: life style intervention Behavioral: lifestyle
lifestyle intervention, including diet, physical activity and behavioral changes



Primary Outcome Measures :
  1. hormonal and metabolic changes during weight loss [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 27 kg/m2 (adults)

Exclusion Criteria:

  • pregnancy, breastfeeding
  • patients with:

    • heart failure
    • impaired hepatic or renal function
    • anaemia
    • disturbed coagulation
    • infection, malabsorption
    • severe hypertension
    • any other endocrine disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953264


Locations
Germany
Charite
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00953264     History of Changes
Other Study ID Numbers: EA4/042/07
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: January 2016

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms