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Effects of Negative Energy Balance on Muscle Mass Regulation

This study is not yet open for participant recruitment.
Verified April 2010 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01105143
First received: April 14, 2010
Last updated: April 15, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Negative Energy Balance on Muscle Mass Regulation

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 14, 2010
Last Updated: April 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Marfan Syndrome
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 23, 2013