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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention | Active Comparator | Multimodal lifestyle intervention to reduce body weight |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal lifestyle intervention | Behavioral | multimodal lifestyle intervention will be performed to reduce body weight |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on energy expenditure | Measurement of energy expenditure (kcal/d), postprandial thermogenesis (%) and respiratory coefficient | 4 months |
| Effects on myocellular and adipose tissue metabolism and substrate utilization |
| Measure | Description | Time Frame |
|---|---|---|
| FFA during negative energy balance and during stabilized modification of body composition after weight loss. | 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. |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Mai, Prof | Charite | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863292 | Derived | 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. | |
| 35379337 |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| placebo | Behavioral | no intervention, only follow up |
|
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 | Analysis of myocellular and adipose mRNA expression (RNA sequencing) in counts | 4 months |
| Weight regain | Analysis of body weight regain (BMI; kg/m2) during follow up | 24 months |
| Fat mass | 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 | 16S rRNA sequencing and/or shotgun metagenomic pyrosequencing of the gut microbiota for assessment of microbiota composition and gene abundances. | 4 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 |
| 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. |
| 29761785 | Derived | 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. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |