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OpenTrials
Completed

NCT Number: NCT01105143

Effects of Negative Energy Balance on Muscle Mass Regulation

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity/Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skeletal Muscle

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charite

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal lifestyle intervention

Behavioral

multimodal lifestyle intervention will be performed to reduce body weight

Placebo

Behavioral

no intervention, only follow up

Primary outcomes

  1. Changes of myocellular insulin sensitivity (hyperinsulinemic clamp) during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 4 months

    Analysis of myocellular insulin sensitivity by hyperinsulinemic clamp in mg•kg-1•min-1/(mU•L-1)

  2. Changes of skeletal muscle mass (air displacement plethysmography) during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 4 months

    Analysis of muscle mass (in % of body weight)

Secondary outcomes

  1. Effects on energy expenditure

    Time frame: 4 months

    Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient

  2. Effects on myocellular and adipose tissue metabolism and substrate utilization

    Time frame: 4 months

    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)

  3. Effects on myocellular and adipose tissue mRNA expression

    Time frame: 4 months

    Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts

  4. Weight regain

    Time frame: 24 months

    Analysis of body weight regain (BMI; kg/m2) during follow up

  5. Fat mass

    Time frame: 24 months

    Analysis of body fat (kg and %)

  6. 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

    Time frame: 4 months

    16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.

Other outcomes

  1. FFA during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of fatty acids at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  2. Metanephrines during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of metanephrines at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  3. Leptin during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of leptin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  4. Cortisol during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of cortisol at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  5. Follistatin during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of follistatin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  6. Adiponectin during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement adiponectin at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  7. Natriuretic peptide during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of natriuretic peptide at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  8. IGF-1 during negative energy balance and during stabilized modification of body composition after weight loss.

    Time frame: 12 months

    Measurement of IGF-1 at baseline, during negative energy balance, during stabilized modification of body composition after weight loss and during follow up.

  9. Analysis of predictive impact of several hormonal and metabolic parameters on body weight regain, course of insulin sensitivity and metabolism

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Apr 16, 2010
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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