Hormonal Regulation of Body Weight Maintenance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014