Hormonal and Metabolic Effects of Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
The investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.

Condition Intervention
Behavioral: lifestyle

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormonal and Metabolic Effects of Weight Loss

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • hormonal and metabolic changes during weight loss [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: lifestyle
    lifestyle intervention, including diet, physical activity and behavioral changes

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953264

Contact: Joachim Spranger, Prof. joachim.spranger@charite.de

Charite Recruiting
Berlin, Germany, 12200
Contact: Joacim Spranger, Prof.       joachim.spranger@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Responsible Party: Professor J. Spranger, Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
ClinicalTrials.gov Identifier: NCT00953264     History of Changes
Other Study ID Numbers: EA4/042/07 
Study First Received: August 5, 2009
Last Updated: August 5, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 26, 2016