Hormonal Regulation of Body Weight Maintenance
12 januari 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
286
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Berlin, Tyskland, 12200
- Charité
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
10 år till 90 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: placebo
Placebo
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inga ingrepp, bara uppföljning
|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Tidsram: 21 months
|
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.
|
21 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of leptin during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of leptin during follow up
Tidsram: 48 months
|
Measurement of leptin during follow up until the 48 months
|
48 months
|
|
Evaluation of catecholamines during follow up
Tidsram: 48 months
|
Measurement of catecholamines during follow up until the 48 months
|
48 months
|
|
Evaluation of catecholamines during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of cortisol during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of cortisol during follow up
Tidsram: 48 months
|
Measurement of cortisol during follow up until the 48 months
|
48 months
|
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Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of GLP1 during follow up
Tidsram: 48 months
|
Measurement of GLP1 during follow up until the 48 months
|
48 months
|
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Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of GIP during follow up
Tidsram: 48 months
|
Measurement of GIP during follow up until the 48 months
|
48 months
|
|
Evaluation of thyroid hormones during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of thyroid hormones during follow up
Tidsram: 48 months
|
Measurement of thyroid hormones during follow up until the 48 months
|
48 months
|
|
Evaluation of insulin during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of insulin during follow up
Tidsram: 48 months
|
Measurement of insulin during follow up until the 48 months
|
48 months
|
|
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18
|
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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of IGF1 during follow up
Tidsram: 48 months
|
Measurement of IGF1 during follow up until the 48 months
|
48 months
|
|
Evaluation of natriuretic peptide during lifestyle intervention
Tidsram: 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
|
month -3, month 0, month 12, month 18
|
|
Evaluation of natriuretic peptide during follow up
Tidsram: 48 months
|
Measurement of natriuretic peptide during follow up until the 48 months
|
48 months
|
|
Evaluation of blood pressure during lifestyle intervention
Tidsram: 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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Tidsram: 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
|
|
Evaluation of respiratory coefficient during lifestyle intervention
Tidsram: month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
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)
Tidsram: month -3, month 0, month 12
|
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
Tidsram: 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)
|
month -3, month 0, month 12
|
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Prediction of body weight regain
Tidsram: month 18, month 48
|
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
|
month 18, month 48
|
|
Prediction of insulin sensitivity
Tidsram: month 18, month 48
|
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
|
month 18, month 48
|
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Prediction of energy expenditure
Tidsram: month 18, month 48
|
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
|
month 18, month 48
|
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Prediction of muscle mass
Tidsram: month 18, month 48
|
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
|
month 18, month 48
|
|
Prediction of fat mass
Tidsram: month 18, month 48
|
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
|
month 18, month 48
|
|
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Tidsram: month 24, month 36, month 48
|
BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
|
month 24, month 36, month 48
|
|
changes of fatty acids during the intervention
Tidsram: 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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
|
changes acylcarnitines
Tidsram: month -3, month 0
|
Analysis of acylcarnitines at baseline and after 3 months of weight loss
|
month -3, month 0
|
|
changes acylcarnitines
Tidsram: month 12, month 18, month 24, month 36, month 48
|
Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
|
month 12, month 18, month 24, month 36, month 48
|
|
body composition
Tidsram: month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
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
|
month -3, month 0, month 12, month 18, month 24, month 36, month 48
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2010
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
17 februari 2009
Först inskickad som uppfyllde QC-kriterierna
24 februari 2009
Första postat (Uppskatta)
25 februari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EA2/017/09
Plan för individuella deltagardata (IPD)
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