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Hormonal and Metabolic Effects of Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lifestyle
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 5, 2009
Last Updated
December 14, 2017
Sponsor
Charite University, Berlin, Germany
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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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