Effects of Negative Energy Balance on Muscle Mass Regulation

Obesity Clinical Trial

Official title:

Effects of Negative Energy Balance on Muscle Mass Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105143
• Other study ID #: EA 20100415
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: December 18, 2017
• Start date: March 2012
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI > 27 kg/m2 (adults)

• postmenopausal state

Exclusion criteria:

• weight loss of more than 5kg in the last 2 months x

• unhealthy patients with: severe chronic diseases including cancer within the last 5 years, severe heart disease, severe impairment of hepatic or renal function, severe anaemia or disturbed coagulation

• eating disorders or any other psychiatric condition that would interact with the trial intervention

• malabsorption

• acute or chronic infections

• severe hypertension

• myopathy

• food allergies

• any other uncontrolled endocrine disorder

• changes of smoking habits, diets or medication that strongly affects energy homeostasis within the last 3 months prior to study inclusion

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity/Resistance
• Obesity
• Skeletal Muscle
• Weight Loss

Intervention

Behavioral:
• multimodal lifestyle intervention
multimodal lifestyle intervention will be performed to reduce body weight
• placebo
no intervention, only follow up

Locations

Country	Name	City	State
Germany	Charite	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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.	12 months
Other	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	24 months
Primary	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)	4 months
Primary	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)	4 months
Secondary	Effects on energy expenditure	Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient	4 months
Secondary	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)	4 months
Secondary	Effects on myocellular and adipose tissue mRNA expression	Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts	4 months
Secondary	Weight regain	Analysis of body weight regain (BMI; kg/m2) during follow up	24 months
Secondary	Fat mass	Analysis of body fat (kg and %)	24 months
Secondary	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.	4 months