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Hormonal Regulation of Body Weight Maintenance

12. januar 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

286

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 12200
        • Charité

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år til 90 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Placebo
Adfærdsmæssigt: placebo
ingen indgriben, kun opfølgning
Eksperimentel: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Adfærdsmæssigt: multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of leptin during lifestyle intervention
Tidsramme: 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
Tidsramme: 48 months
Measurement of leptin during follow up until the 48 months
48 months
Evaluation of catecholamines during follow up
Tidsramme: 48 months
Measurement of catecholamines during follow up until the 48 months
48 months
Evaluation of catecholamines during lifestyle intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 48 months
Measurement of cortisol during follow up until the 48 months
48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Tidsramme: 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
Tidsramme: 48 months
Measurement of GLP1 during follow up until the 48 months
48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Tidsramme: 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
Tidsramme: 48 months
Measurement of GIP during follow up until the 48 months
48 months
Evaluation of thyroid hormones during lifestyle intervention
Tidsramme: 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
Tidsramme: 48 months
Measurement of thyroid hormones during follow up until the 48 months
48 months
Evaluation of insulin during lifestyle intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 48 months
Measurement of IGF1 during follow up until the 48 months
48 months
Evaluation of natriuretic peptide during lifestyle intervention
Tidsramme: 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
Tidsramme: 48 months
Measurement of natriuretic peptide during follow up until the 48 months
48 months
Evaluation of blood pressure during lifestyle intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: month -3, month 0
Analysis of acylcarnitines at baseline and after 3 months of weight loss
month -3, month 0
changes acylcarnitines
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Samarbejdspartnere

German Research Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

17. februar 2009

Først indsendt, der opfyldte QC-kriterier

24. februar 2009

Først opslået (Skøn)

25. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EA2/017/09

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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