Effects of Negative Energy Balance on Muscle Mass Regulation

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT01105143
• Collaborator: German Research Foundation (Other)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 62
• Patients Per Site Per Month: 1.3

Study Details

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	Phase
Weight Loss; Obesity; Skeletal Muscle; Insulin Sensitivity/Resistance	Behavioral: multimodal lifestyle intervention; Behavioral: placebo	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2017

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. [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. [4 months]

   Analysis of muscle mass (in % of body weight)

Secondary Outcome Measures

1. Effects on energy expenditure [4 months]

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

2. Effects on myocellular and adipose tissue metabolism and substrate utilization [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 [4 months]

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

4. Weight regain [24 months]

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

5. Fat mass [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 [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. [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. [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. [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. [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. [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. [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. [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. [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 [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

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Charite	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany
• German Research Foundation

Investigators

• Principal Investigator: Knut Mai, Prof, Charite

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01105143
• Other Study ID Numbers: EA 20100415
• First Posted: Apr 16, 2010
• Last Update Posted: Dec 20, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Professor Joachim Spranger, Professor, Charite University, Berlin, Germany: weight loss; muscle mass
• Additional relevant MeSH terms: Insulin Resistance; Weight Loss

Study Results

No Results Posted as of Dec 20, 2017