Hormonal and Metabolic Effects of Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI > 27 kg/m2 (adults)
Exclusion Criteria:
- pregnancy, breastfeeding
patients with:
- heart failure
- impaired hepatic or renal function
- anaemia
- disturbed coagulation
- infection, malabsorption
- severe hypertension
- any other endocrine disorder
Sites / Locations
- Charite
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
life style intervention
Arm Description
Outcomes
Primary Outcome Measures
hormonal and metabolic changes during weight loss
Secondary Outcome Measures
Full Information
NCT ID
NCT00953264
First Posted
August 5, 2009
Last Updated
December 14, 2017
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00953264
Brief Title
Hormonal and Metabolic Effects of Weight Loss
Official Title
Hormonal and Metabolic Effects of Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
life style intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
lifestyle
Intervention Description
lifestyle intervention, including diet, physical activity and behavioral changes
Primary Outcome Measure Information:
Title
hormonal and metabolic changes during weight loss
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI > 27 kg/m2 (adults)
Exclusion Criteria:
pregnancy, breastfeeding
patients with:
heart failure
impaired hepatic or renal function
anaemia
disturbed coagulation
infection, malabsorption
severe hypertension
any other endocrine disorder
Facility Information:
Facility Name
Charite
City
Berlin
ZIP/Postal Code
12200
Country
Germany
12. IPD Sharing Statement
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Hormonal and Metabolic Effects of Weight Loss
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