Clinical trial NCT01344525: Pilot Project on Interdisciplinary Therapy of Obesity
Official title: Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: obesity therapy
metabolic syndrome
gastrointestinal tract
microbiota
metabolomics
micronutrients
outcome
sustainability
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-04-29
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Obese individuals that undergo major intervention such as a low-calorie formula diet program or bariatric surgery with the result of substantial weight loss (\> 10%) are included and followed-up for at least 3 years. Weight changes and excess weight loss as well as measures of quality of life are monitored. In addition, biomaterials will be collected from these individuals every 6 months for measurement of parameters related to obesity-associated gastrointestinal (GI) impairments such as change in GI hormone levels, change in GI microbiota, or enhanced bacterial translocation. Moreover, micronutrient and metabolomics analysis will be performed. This project allows comparison of non-surgical and surgical intervention and enables to asses the anticipated relationship between obesity and the GI tract in humans in the future.

Detailed description: A database and a biomaterial bank will be established to assess, if the role of the gut for the development of obesity and obesity-related diseases such as fatty liver are of relevance in humans, e.g. for classification of afflicted individuals regarding risk or outcome after intervention. During 3 years, the investigators will include 480 obese individuals (4 cohorts of 120 individuals) who undergo a treatment program (either surgical or non-surgical), and follow them up for at least 3 years. Every 6 months, a visit is planned at the obesity center where the initial intervention has been performed. Within the visits, anthropometry (Body Mass Index (BMI), excess body weight (EBW), bioelectrical impedance analysis (BIA)), quality of life (SF36 score, Impact Of Weight On Quality Of Life (IWQOL) questionnaire), and sample collection for laboratory analyses (inflammatory markers, hormones, flora composition, micronutrients, metabolomics etc.) will be performed. Patients will be recruited from 3 centers in Germany. The long-term expectation from this model project is to find gastrointestinal parameters allowing to predict outcome and sustainability of different intervention strategies. In addition, intervention programs will be compared regarding long-term outcome and quality of life changes.

Eligibility criteria: Inclusion Criteria:

* Adults (18-65 years at time of inclusion)
* Obesity defined as BMI \> 30 kg/m2
* Obesity treatment (multidisciplinary life style intervention with LCD or bariatric surgery) resulting in an estimated body weight loss of \>10% of the initial body weight within 6 month

Exclusion Criteria:

* Body weight loss after intervention \< 10%
* Follow-up period \< 1 year or number of consultations within 3 years \< 3

Primary outcomes:
measure: Body weight loss
timeFrame: Every 6 months for a period of 3 years
Secondary outcomes:
measure: Quality of life
timeFrame: Every 6 months for a period of 3 years
measure: Physical examination
timeFrame: Every 6 months for a period of 3 years
measure: Laboratory analysis
timeFrame: Every 6 months for a period of 3 years
measure: Vitamins/micronutrients
timeFrame: Every 3-6 months for a period of maximal 3 years
measure: Metabolomics, and Microflora analysis
timeFrame: Every 3-6 months for a period of maximal 3 years
measure: Liver fat
timeFrame: Every 6 months for a period of 3 years
measure: gut permeability
timeFrame: Every 6 months for a period of 3 years
measure: peripheral blood lipopolysaccharide concentrations
timeFrame: Every 6 months for a period of 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Stuttgart
country: Germany
facility: University of Hohenheim
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
affiliation: University of Hohenheim, Institute of Nutritional Medicine
name: Stephan C. Bischoff, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damms-Machado A, Louis S, Schnitzer A, Volynets V, Rings A, Basrai M, Bischoff SC. Gut permeability is related to body weight, fatty liver disease, and insulin resistance in obese individuals undergoing weight reduction. Am J Clin Nutr. 2017 Jan;105(1):127-135. doi: 10.3945/ajcn.116.131110. Epub 2016 Nov 9.
citation: Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1.
citation: Damms-Machado A, Weser G, Bischoff SC. Micronutrient deficiency in obese subjects undergoing low calorie diet. Nutr J. 2012 Jun 1;11:34. doi: 10.1186/1475-2891-11-34.
citation: Damms-Machado A, Friedrich A, Kramer KM, Stingel K, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Pre- and postoperative nutritional deficiencies in obese patients undergoing laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jun;22(6):881-9. doi: 10.1007/s11695-012-0609-0.