Effects of Negative Energy Balance on Muscle Mass Regulation

December 18, 2017 updated by: Professor Joachim Spranger, Charite University, Berlin, Germany
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Behavioral: placebo
no intervention, only follow up
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 months
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)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on energy expenditure
Time Frame: 4 months
Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient
4 months
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)
4 months
Effects on myocellular and adipose tissue mRNA expression
Time Frame: 4 months
Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts
4 months
Weight regain
Time Frame: 24 months
Analysis of body weight regain (BMI; kg/m2) during follow up
24 months
Fat mass
Time Frame: 24 months
Analysis of body fat (kg and %)
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
Time Frame: 4 months
16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA 20100415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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