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Hormonal Regulation of Body Weight Maintenance

12. Januar 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

286

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

10 Jahre bis 90 Jahre (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Verhalten: Placebo
Keine Intervention, nur Nachbereitung
Experimental: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Verhalten: multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of leptin during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of leptin during follow up until the 48 months
48 months
Evaluation of catecholamines during follow up
Zeitfenster: 48 months
Measurement of catecholamines during follow up until the 48 months
48 months
Evaluation of catecholamines during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of cortisol during follow up until the 48 months
48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of GLP1 during follow up until the 48 months
48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of GIP during follow up until the 48 months
48 months
Evaluation of thyroid hormones during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of thyroid hormones during follow up until the 48 months
48 months
Evaluation of insulin during lifestyle intervention
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 48 months
Measurement of IGF1 during follow up until the 48 months
48 months
Evaluation of natriuretic peptide during lifestyle intervention
Zeitfenster: month -3, month 0, month 12, month 18
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
Zeitfenster: 48 months
Measurement of natriuretic peptide during follow up until the 48 months
48 months
Evaluation of blood pressure during lifestyle intervention
Zeitfenster: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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
Zeitfenster: month -3, month 0, month 12, month 18, month 24, month 36, month 48
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
month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of respiratory coefficient during lifestyle intervention
Zeitfenster: 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)
Zeitfenster: month -3, month 0, month 12
Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
month -3, month 0, month 12
Measurement of insulin sensitivity
Zeitfenster: month -3, month 0, month 12
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
Prediction of body weight regain
Zeitfenster: 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
Zeitfenster: 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
Prediction of energy expenditure
Zeitfenster: 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
Prediction of muscle mass
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: month -3, month 0
Analysis of acylcarnitines at baseline and after 3 months of weight loss
month -3, month 0
changes acylcarnitines
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Charite University, Berlin, Germany

Mitarbeiter

German Research Foundation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2010

Primärer Abschluss (Tatsächlich)

1. Dezember 2015

Studienabschluss (Tatsächlich)

1. Januar 2016

Studienanmeldedaten

Zuerst eingereicht

17. Februar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Februar 2009

Zuerst gepostet (Schätzen)

25. Februar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Januar 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Januar 2018

Zuletzt verifiziert

1. Januar 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EA2/017/09

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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