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Effects of Negative Energy Balance on Muscle Mass Regulation

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ClinicalTrials.gov Identifier: NCT01105143
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Weight Loss Obesity Skeletal Muscle Insulin Sensitivity/Resistance Behavioral: multimodal lifestyle intervention Behavioral: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Negative Energy Balance on Muscle Mass Regulation
Actual Study Start Date : March 2012
Primary Completion Date : May 2015
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: lifestyle intervention
Multimodal lifestyle intervention to reduce body weight
Behavioral: multimodal lifestyle intervention
multimodal lifestyle intervention will be performed to reduce body weight
Placebo Comparator: placebo
placebo
Behavioral: placebo
no intervention, only follow up


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105143


Locations
Germany
Charite
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Principal Investigator: Knut Mai, Prof Charite
More Information

Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01105143     History of Changes
Other Study ID Numbers: EA 20100415
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by Professor Joachim Spranger, Charite University, Berlin, Germany:
weight loss
muscle mass

Additional relevant MeSH terms:
Weight Loss
Insulin Resistance
Body Weight Changes
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases