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Hormonal Regulation of Body Weight Maintenance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Professor Joachim Spranger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00850629
First received: February 17, 2009
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Weight Regain
 Behavioral: multimodal lifestyle intervention
Behavioral: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormonal Regulation of Body Weight Maintenance

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Weight regain during lifestyle intervention in children, adolescents and adults vs. placebo [ Time Frame: 18 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of several endocrine parameters during lifestyle intervention in children, adolescents and adults [ Time Frame: 18 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: October 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Placebo
 Behavioral: placebo
no intervention, only follow up
Experimental: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
 Behavioral: multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 27 kg/m2 (adults)

Exclusion Criteria:

  • weight loss of more than 5kg in the last 2 months
  • pregnancy, breastfeeding

  • patients with:

    • heart failure
    • impaired hepatic or renal function
    • anaemia
    • disturbed coagulation
    • infection, malabsorption
    • severe hypertension
    • any other endocrine disorder
  • changes of smoking habits or diets within the last 3 months prior to study inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850629

Locations
Germany
Charite
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
  More Information

No publications provided

Responsible Party: Professor Joachim Spranger, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00850629     History of Changes
Other Study ID Numbers: EA2/017/09
Study First Received: February 17, 2009
Last Updated: January 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
weight regain
endocrine counterregulation

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013