Hormonal Regulation of Body Weight Maintenance
12 gennaio 2018 aggiornato da: Professor Joachim Spranger, Charite University, Berlin, Germany
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults.
The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss.
Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
286
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Berlin, Germania, 12200
- Charité
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 10 anni a 90 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- BMI > 27 kg/m2 (adults)
Exclusion Criteria:
- weight loss of more than 5kg in the last 2 months
- pregnancy, breastfeeding
patients with:
- severe heart failure
- impaired hepatic or renal function
- anaemia
- disturbed coagulation (biopsies will not be taken in those subjects)
- infection, malabsorption
- severe hypertension
- cancer within the last 5 years
- eating disorders or any other psychiatric condition that would interact with the trial intervention
- any other endocrine disorder
- changes of smoking habits or diets within the last 3 months prior to study inclusion
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: placebo
Placebo
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nessun intervento, solo follow-up
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Sperimentale: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
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After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Lasso di tempo: 21 months
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BMI (kg/m2) will be analyzed after intentional weight loss in two comparable parts of a randomized controlled trial including (1) children and adolescents and (2) adults.
Therefore effects of a multimodal lifestyle intervention will be compared to placebo.
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21 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluation of leptin during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of leptin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of leptin during follow up
Lasso di tempo: 48 months
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Measurement of leptin during follow up until the 48 months
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48 months
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Evaluation of catecholamines during follow up
Lasso di tempo: 48 months
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Measurement of catecholamines during follow up until the 48 months
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48 months
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Evaluation of catecholamines during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of catecholamines at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
|
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Evaluation of cortisol during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of cortisol at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of cortisol during follow up
Lasso di tempo: 48 months
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Measurement of cortisol during follow up until the 48 months
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48 months
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Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of GLP1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of GLP1 during follow up
Lasso di tempo: 48 months
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Measurement of GLP1 during follow up until the 48 months
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48 months
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Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of GIP at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of GIP during follow up
Lasso di tempo: 48 months
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Measurement of GIP during follow up until the 48 months
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48 months
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Evaluation of thyroid hormones during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of thyroid hormones at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
|
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Evaluation of thyroid hormones during follow up
Lasso di tempo: 48 months
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Measurement of thyroid hormones during follow up until the 48 months
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48 months
|
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Evaluation of insulin during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of insulin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of insulin during follow up
Lasso di tempo: 48 months
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Measurement of insulin during follow up until the 48 months
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48 months
|
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Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of IGF1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of IGF1 during follow up
Lasso di tempo: 48 months
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Measurement of IGF1 during follow up until the 48 months
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48 months
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Evaluation of natriuretic peptide during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18
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Measurement of natriuretic peptide at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
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month -3, month 0, month 12, month 18
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Evaluation of natriuretic peptide during follow up
Lasso di tempo: 48 months
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Measurement of natriuretic peptide during follow up until the 48 months
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48 months
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Evaluation of blood pressure during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Measurement of blood pressure at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Evaluation of free fatty acids (FFAs) during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Measurement of FFAs at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Evaluation of respiratory coefficient during lifestyle intervention
Lasso di tempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Measurement of respiratory coefficient at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Measurement of messenger ribonucleic acid (mRNA) changes in adipose and skeletal muscle before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Lasso di tempo: month -3, month 0, month 12
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Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
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month -3, month 0, month 12
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Measurement of insulin sensitivity
Lasso di tempo: month -3, month 0, month 12
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Measurement of systemic and tissue specific changes in adipose and muscle insulin sensitivity using hyperinsulinemic clamp (mg•kg-1•min-1/(mU•L-1)) before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
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month -3, month 0, month 12
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Prediction of body weight regain
Lasso di tempo: month 18, month 48
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No additional measurement will be done.
However, we will analyse the predictive impact of already measured parameters on long-term course of BMI (18 and 48 months) using mathematical models
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month 18, month 48
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Prediction of insulin sensitivity
Lasso di tempo: month 18, month 48
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No additional measurement will be done.
However, we will analyse the predictive impact of already measured parameters on insulin sensitivity (18 and 48 months) using mathematical models
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month 18, month 48
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Prediction of energy expenditure
Lasso di tempo: month 18, month 48
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No additional measurement will be done.
However, we will analyse the predictive impact of already measured parameters on energy expenditure (18 and 48 months) using mathematical models
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month 18, month 48
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Prediction of muscle mass
Lasso di tempo: month 18, month 48
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No additional measurement will be done.
However, we will analyse the predictive impact of already measured parameters on muscle mass (18 and 48 months) using mathematical models
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month 18, month 48
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Prediction of fat mass
Lasso di tempo: month 18, month 48
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No additional measurement will be done.
However, we will analyse the predictive impact of already measured parameters on fat mass (18 and 48 months) using mathematical models
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month 18, month 48
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BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Lasso di tempo: month 24, month 36, month 48
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BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
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month 24, month 36, month 48
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changes of fatty acids during the intervention
Lasso di tempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
Analysis of fatty acids at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month -3, month 0, month 12, month 18, month 24, month 36, month 48
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changes acylcarnitines
Lasso di tempo: month -3, month 0
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Analysis of acylcarnitines at baseline and after 3 months of weight loss
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month -3, month 0
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changes acylcarnitines
Lasso di tempo: month 12, month 18, month 24, month 36, month 48
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Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month 12, month 18, month 24, month 36, month 48
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body composition
Lasso di tempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Whole body fat mass (kg, %) will be measured at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
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month -3, month 0, month 12, month 18, month 24, month 36, month 48
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Li L, Soll D, Leupelt V, Spranger J, Mai K. Weight loss-induced improvement of body weight and insulin sensitivity is not amplified by a subsequent 12-month weight maintenance intervention but is predicted by adaption of adipose atrial natriuretic peptide system: 48-month results of a randomized controlled trial. BMC Med. 2022 Jul 28;20(1):238. doi: 10.1186/s12916-022-02435-9.
- Soll D, Gawron J, Pletsch-Borba L, Spranger J, Mai K. Long-term impact of the metabolic status on weight loss-induced health benefits. Nutr Metab (Lond). 2022 Mar 28;19(1):25. doi: 10.1186/s12986-022-00660-w.
- Li L, Spranger L, Stobaus N, Beer F, Decker AM, Wernicke C, Brachs S, Brachs M, Spranger J, Mai K. Fetuin-B, a potential link of liver-adipose tissue cross talk during diet-induced weight loss-weight maintenance. Nutr Diabetes. 2021 Oct 5;11(1):31. doi: 10.1038/s41387-021-00174-z.
- Li L, Spranger L, Soll D, Beer F, Brachs M, Spranger J, Mai K. Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections? Metabolism. 2020 Dec;113:154401. doi: 10.1016/j.metabol.2020.154401. Epub 2020 Oct 13.
- Brachs S, Polack J, Brachs M, Jahn-Hofmann K, Elvert R, Pfenninger A, Barenz F, Margerie D, Mai K, Spranger J, Kannt A. Genetic Nicotinamide N-Methyltransferase (Nnmt) Deficiency in Male Mice Improves Insulin Sensitivity in Diet-Induced Obesity but Does Not Affect Glucose Tolerance. Diabetes. 2019 Mar;68(3):527-542. doi: 10.2337/db18-0780. Epub 2018 Dec 14.
- Mai K, Li L, Wiegand S, Brachs M, Leupelt V, Ernert A, Kuhnen P, Hubner N, Robinson P, Chen W, Krude H, Spranger J. An Integrated Understanding of the Molecular Mechanisms of How Adipose Tissue Metabolism Affects Long-term Body Weight Maintenance. Diabetes. 2019 Jan;68(1):57-65. doi: 10.2337/db18-0440. Epub 2018 Nov 2.
- Bau AM, Ernert A, Krude H, Wiegand S. Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15. BMC Obes. 2016 Jun 10;3:29. doi: 10.1186/s40608-016-0110-8. eCollection 2016.
- Brachs M, Wiegand S, Leupelt V, Ernert A, Kintscher U, Jumpertz von Schwarzenberg R, Decker AM, Bobbert T, Hubner N, Chen W, Krude H, Spranger J, Mai K. ANP system activity predicts variability of fat mass reduction and insulin sensitivity during weight loss. Metabolism. 2016 Jun;65(6):935-43. doi: 10.1016/j.metabol.2016.03.013. Epub 2016 Apr 7.
- Weygandt M, Mai K, Dommes E, Ritter K, Leupelt V, Spranger J, Haynes JD. Impulse control in the dorsolateral prefrontal cortex counteracts post-diet weight regain in obesity. Neuroimage. 2015 Apr 1;109:318-27. doi: 10.1016/j.neuroimage.2014.12.073. Epub 2015 Jan 7.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2010
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 gennaio 2016
Date di iscrizione allo studio
Primo inviato
17 febbraio 2009
Primo inviato che soddisfa i criteri di controllo qualità
24 febbraio 2009
Primo Inserito (Stima)
25 febbraio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 gennaio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 gennaio 2018
Ultimo verificato
1 gennaio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EA2/017/09
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .