Effects of Negative Energy Balance on Muscle Mass Regulation

Charite University, Berlin, Germany81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Weight Loss Obesity Skeletal Muscle Insulin Sensitivity/Resistance

Interventions

multimodal lifestyle interventionBEHAVIORAL

multimodal lifestyle intervention will be performed to reduce body weight

placeboBEHAVIORAL

no intervention, only follow up

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Charite

Berlin, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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