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Unbiased DECONvolution of obesity

Organizational Data

DRKS-ID:
DRKS00015814
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-11-09
Last update in DRKS:
2023-07-10
Registration type:
Prospective

Acronym/abbreviation of the study

DECON

URL of the study

No Entry

Brief summary in lay language

Current BMI-based classification of obesity is very pragmatic and feasible, but does not allow diagnostic or prognostic differentiation between patient subgroups. Even under highly standardized therapeutic conditions patients with identical BMI-values and similar co-morbidity differ greatly regarding postoperative weight loss and remission of associated disease. Treatment success is often defined as >50% Excess Weight Loss. This definition implies obese patients with similar BMI-values and comparable co-morbidity will fair comparably well. This does not reflect clinical reality that shows considerable deviations regarding weight loss. There are various subgroups of obesity patients that differ in etiology, predisposition and treatment prognosis. This study serves as a pilot study to unterstand more clearly the diversity of patient subsets that exist on the basis of unbiased, high-dimensional data and to create the basis of a new classification system. In the pilot phase, we collect preliminary data, establish analytical pipelines and optimize bioinformatic approach.

Brief summary in scientific language

Prevalence of overweight and obesity has been increasing worldwide in the past years. Obesity is a chronic disease with a high rate of recurrence and countless associated diseases, first and foremost diabetes. Disease etiology is very complex. A positive energy balance, which is aggravated by increasing sedentary behavior and easy access to high-caloric foods plays a central role. Genetics, family predisposition and environmental factors contribute to an individual's risk profile. Furthermore, in the past years data has been obtained underlining the importance of intergenerational metabolic programming on an epigenetic level. Obesity is still very poorly understood on many levels. Current classification systems reflect this and employ pragmatic criteria, almost exclusively BMI-oriented. We plan in a multi-center trial and in collaboration with the Max Planck Institut für Immunbiologie und Epigenetik to examine a large patient population to create the foundation of a new and more precise classification system. Patient clustering will be achieved on the basis of unbiased high-dimensional sequencing data. These data will be correlated with clinical parameters. Our goal is to individualize diagnosis and treatment prognosis of obesity patients. During the pilot phase we plan to establish logistics and analytic pipelines as well as optimize bioinformatic approach.

Health condition or problem studied

ICD10:
E66 - Obesity
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Liver and adipose biopsies during bariatric/metabolic surgery

Endpoints

Primary outcome:
This study has no comparative outcome. The focus lies in its bioinformatic approach which relies on dimensional reduction and clustering of RNAseq-data and quantifiable clinical parameters to define patient clusters. In this way the entire spectrum currently globally termed as obesity will be more precisely defined.
Secondary outcome:
see primary outcome

Study Design

Purpose:
Basic research/physiological study
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Allgemein- und Viszeralchirurgie Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2018-11-26
Actual study start date:
2018-11-26
Planned study completion date:
No Entry
Actual Study Completion Date:
2020-12-17
Target Sample Size:
50
Final Sample Size:
50

Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
49 Years
Additional Inclusion Criteria:
1) Obesity WHO III (BMI>40 kg/m2) 2) Obesity WHO II (BMI 35-40 kg/m2) + obesity related diseases (diabetes, hypertension, hyperlipidemia, osteoarthrosis, obstructive sleep apnea, obesity hypoventilation syndrome, nonalcoholic fatty liver disease (NAFLD) and/or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, impaired quality of life, disqualification for other surgeries as a result of obesity (i.e., surgeries for osteoarthritic disease, ventral hernias, or stress incontinence) Female, caucasian, >=18 years <50 years

Exclusion Criteria

Patients with high perioperative risk, previous bariatric surgery, carcinoma within the last 5 years, severe psychiatric disease, drug or alcohol abuse,

Addresses

Primary Sponsor

Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
PD Dr. Gabriel Seifert
Hugstetter Straße 55
79106 Freiburg
Germany
Telephone:
+49 761 270 24010
Fax:
+49 761 270 28080
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/de.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
PD Dr. Gabriel Seifert
Hugstetter Straße 55
79106 Freiburg
Germany
Telephone:
+49 761 270 24010
Fax:
+49 761 270 28080
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/de.html

Contact for Public Queries

Universitätsklinikum Freiburg Abteilung Allgemien- und Viszeralchirurgie
Olivia Sick
Hugstetter Str. 55
79106 Freiburg
Germany
Telephone:
0761/270-28080
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Principal Investigator

Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
PD Dr. Gabriel Seifert
Hugstetter Straße 55
79106 Freiburg
Germany
Telephone:
+49 761 270 24010
Fax:
+49 761 270 28080
Contact per E-Mail
URL:
https://www.uniklinik-freiburg.de/de.html

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Max-Planck-Institut für Immunbiologie und Epigenetik
Stübeweg 51
79108 Freiburg
Germany
Telephone:
+49 761 5108-0
Fax:
+49 761 5108-220
Contact per E-Mail
URL:
https://www.ie-freiburg.mpg.de/de/pospisilik

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-05-07
Ethics committee number:
194/18
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-09-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1212-4671
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Not available

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry