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Effects of Negative Energy Balance on Muscle Mass Regulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105143
First Posted: April 16, 2010
Last Update Posted: April 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
  Purpose
The investigators here propose to perform a prospective randomized intervention trial in post-menopausal women to investigate the endocrine network, which contributes to the changes in skeletal muscle mass during weight loss.

Condition Intervention
Muscle Mass Behavioral: multimodal lifestyle intervention Behavioral: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Negative Energy Balance on Muscle Mass Regulation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To describe the systemic and muscular hormonal response accompanying skeletal muscle mass reduction during negative energy balance and during stabilized modification of body composition after weight loss. [ Time Frame: 3 years ]
    Measurement of systemic and myocellular changes considering IGF-1, chemerin, adiponectin, follistatin, cortisol, 11ß-HSD1, ghrelin and catecholamines


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lifestyle intervention Behavioral: multimodal lifestyle intervention
multimodal lifestyle intervention will be performed to reduce body weight
Placebo Comparator: placebo
placebo
Behavioral: placebo
no intervention, only follow up

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 27 kg/m2 (adults)

Exclusion Criteria:

  • weight loss of more than 5kg in the last 2 months
  • patients with:

    • severe heart failure
    • impaired hepatic or renal function
    • severe anaemia
    • disturbed coagulation
    • infection, malabsorption
    • severe hypertension
    • myopathia
    • any other uncontrolled endocrine disorder
  • changes of smoking habits or diets within the last 3 months prior to study inclusion
  Contacts and Locations
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): NCT01105143


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

Locations
Germany
Charite Not yet recruiting
Berlin, Germany, 12200
Contact: Joachim Spranger, Prof         
Sub-Investigator: Knut Mai, MD         
Sub-Investigator: Thomas Bobbert, MD         
Sub-Investigator: Anke Assmann, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
  More Information

Responsible Party: Professor J. Spranger, Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
ClinicalTrials.gov Identifier: NCT01105143     History of Changes
Other Study ID Numbers: EA 20100415
First Submitted: April 14, 2010
First Posted: April 16, 2010
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by Charite University, Berlin, Germany:
weight loss
muscle mass


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