NCT00773565

Brief Summary

The aim of this study is to understand the metabolic changes occurring in fat tissue both during controlled weight loss that lead to the improvement of type 2 diabetes and other obesity associated metabolic disorders. The novelty of the study is the analysis of preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge of pathways involved in controlling adipose tissue composition will help to design novel intervention strategies for the treatment of obesity associated metabolic disorders such as type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2008

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

October 15, 2008

Last Update Submit

August 22, 2012

Conditions

Obesity

Keywords

patients with obesity (BMI > 30 kg/m2)

Outcome Measures

Primary Outcomes (1)

  • number of adipocytes and preadipocytes under weight loss

    three years

Secondary Outcomes (1)

  • metabolic function of adipocytes and preadipocytes under weight loss

    three years

Study Arms (1)

Optifast

OTHER

Patients included take part at a weight reduction program over one year.

Dietary Supplement: Optifast

Interventions

OptifastDIETARY_SUPPLEMENT

Formula diet for twelve weeks combined with physical activity and behavioral therapy

Optifast

Eligibility Criteria

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

You may qualify if:

  • Participants of the OPTIFAST52 program
  • BMI \> 30 kg/m2

You may not qualify if:

  • Rejection of informed consent by the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian Wolfrum, PhD

    ETH Zürich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Oberarzt

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

DE(1)