An interventional study of multimodal lifestyle intervention and placebo in Weight Loss, Obesity and Skeletal Muscle, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 81 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Multimodal lifestyle intervention to reduce body weight
Behavioral: multimodal lifestyle intervention
placebo
Behavioral: placebo
multimodal lifestyle intervention will be performed to reduce body weight
no intervention, only follow up
Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.
Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)
Time frame: 4 months
Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.
Analysis of muscle mass (in % of body weight)
Time frame: 4 months
Effects on energy expenditure
Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
Time frame: 4 months
Effects on myocellular and adipose tissue metabolism and substrate utilization
Measurement of myocellular and adipose metabolism using microdialysis (glycerol (µmol/l), lactate (mmol/l), pyruvate (µmol/l), glucose (mmol/l)) during oral glucose load (180 minutes)
Time frame: 4 months
Effects on myocellular and adipose tissue mRNA expression
Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
Time frame: 4 months
Weight regain
Analysis of body weight regain (BMI; kg/m2) during follow up
Time frame: 24 months
Fat mass
Analysis of body fat (kg and %)
Time frame: 24 months
Measurement of human gut microbiome at baseline, during weight loos, after weight loss (negative energy balance) and during stabilized modification of body composition 4 weeks after weight loss
16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.
Time frame: 4 months
FFA during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of fatty acids at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Metanephrines during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of metanephrines at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Leptin during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of leptin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Cortisol during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of cortisol at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Follistatin during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of follistatin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Adiponectin during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement adiponectin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Natriuretic peptide during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of natriuretic peptide at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
IGF-1 during negative energy balance and during stabilized modification of body composition after weight loss.
Measurement of IGF-1 at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.
Time frame: 12 months
Analysis of predictive impact of several hormonal and metabolic parameters on body weight regain, course of insulin sensitivity and metabolism
The effect of measured parameters (see other endpoints) on long-term course of BMI, muscle mass, insulin sensitivity and energy expenditure will be analyzed using mathematical models
Time frame: 24 months
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany