Hormonal Regulation of Body Weight Maintenance
12 de enero de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
286
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Berlin, Alemania, 12200
- Charité
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
10 años a 90 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: placebo
Placebo
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sin intervención, solo seguimiento
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of leptin during lifestyle intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Evaluation of cortisol during lifestyle intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 48 months
|
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
Periodo de tiempo: 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
Periodo de tiempo: 48 months
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2010
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
17 de febrero de 2009
Primero enviado que cumplió con los criterios de control de calidad
24 de febrero de 2009
Publicado por primera vez (Estimar)
25 de febrero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de enero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EA2/017/09
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .