NCT00953264

Brief Summary

The investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 15, 2017

Status Verified

January 1, 2016

Enrollment Period

6 years

First QC Date

August 5, 2009

Last Update Submit

December 14, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • hormonal and metabolic changes during weight loss

    6 month

Study Arms (1)

life style intervention

EXPERIMENTAL
Behavioral: lifestyle

Interventions

lifestyleBEHAVIORAL

lifestyle intervention, including diet, physical activity and behavioral changes

life style intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 27 kg/m2 (adults)

You may not qualify if:

  • pregnancy, breastfeeding
  • patients with:
  • heart failure
  • impaired hepatic or renal function
  • anaemia
  • disturbed coagulation
  • infection, malabsorption
  • severe hypertension
  • any other endocrine disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

December 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 15, 2017

Record last verified: 2016-01

Locations

DE(1)