Text Size

Hormonal and Metabolic Effects of Weight Loss

This study is currently recruiting participants.
Verified August 2009 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00953264
First received: August 5, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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


Condition Intervention
Obesity
 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953264

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

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

No publications provided

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013