NCT01105143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

April 14, 2010

Last Update Submit

December 18, 2017

Conditions

Weight LossObesitySkeletal MuscleInsulin Sensitivity/Resistance

Keywords

weight lossmuscle mass

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    4 months

Secondary Outcomes (6)

  • Effects on energy expenditure

    4 months

  • Effects on myocellular and adipose tissue metabolism and substrate utilization

    4 months

  • Effects on myocellular and adipose tissue mRNA expression

    4 months

  • Weight regain

    24 months

  • Fat mass

    24 months

  • +1 more secondary outcomes

Other Outcomes (9)

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

    12 months

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

    12 months

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

    12 months

  • +6 more other outcomes

Study Arms (2)

lifestyle intervention

ACTIVE COMPARATOR

Multimodal lifestyle intervention to reduce body weight

Behavioral: multimodal lifestyle intervention

placebo

PLACEBO COMPARATOR

placebo

Behavioral: placebo

Interventions

multimodal lifestyle interventionBEHAVIORAL

multimodal lifestyle intervention will be performed to reduce body weight

lifestyle intervention
placeboBEHAVIORAL

no intervention, only follow up

placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 27 kg/m2 (adults)
  • postmenopausal state

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite

Berlin, 10117, Germany

Location

Related Publications (3)

  • Spranger L, Weiner J, Bredow J, Zeitz U, Grittner U, Boschmann M, Dickmann S, Stobaus N, Schwartzenberg RJ, Brachs M, Spranger J, Mai K. Thrifty energy phenotype predicts weight regain in postmenopausal women with overweight or obesity and is related to FGFR1 signaling. Clin Nutr. 2023 Apr;42(4):559-567. doi: 10.1016/j.clnu.2023.02.020. Epub 2023 Feb 24.

    PMID: 36863292DERIVED

  • Sbierski-Kind J, Grenkowitz S, Schlickeiser S, Sandforth A, Friedrich M, Kunkel D, Glauben R, Brachs S, Mai K, Thurmer A, Radonic A, Drechsel O, Turnbaugh PJ, Bisanz JE, Volk HD, Spranger J, von Schwartzenberg RJ. Effects of caloric restriction on the gut microbiome are linked with immune senescence. Microbiome. 2022 Apr 4;10(1):57. doi: 10.1186/s40168-022-01249-4.

    PMID: 35379337DERIVED

  • Koppel N, Bisanz JE, Pandelia ME, Turnbaugh PJ, Balskus EP. Discovery and characterization of a prevalent human gut bacterial enzyme sufficient for the inactivation of a family of plant toxins. Elife. 2018 May 15;7:e33953. doi: 10.7554/eLife.33953.

    PMID: 29761785DERIVED

MeSH Terms

Conditions

Weight LossObesityInsulin Resistance

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Knut Mai, Prof

    Charite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 16, 2010

Study Start

March 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

DE(1)