Completed
NA
INTERVENTIONAL
NCT01105143
Effects of Negative Energy Balance on Muscle Mass Regulation
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
multimodal lifestyle intervention
Type:
BEHAVIORAL
Description:
multimodal lifestyle intervention will be performed to reduce body weight
Name:
placebo
Type:
BEHAVIORAL
Description:
no intervention, only follow up
Primary Outcomes
Measure:
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
TimeFrame:
4 months
Description:
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Measure:
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
TimeFrame:
4 months
Description:
Analysis of muscle mass (in % of body weight)
Trial Information
NCT ID
NCT01105143
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Charite University, Berlin, Germany
Last Updated
December 15, 2025