Pilot Project on Interdisciplinary Therapy of Obesity

Официальное название

Pilot Project on Interdisciplinary Therapy of Obesity and Its Consequences on Body Weight, Quality of Life and Gastrointestinal Parameters

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Laparoscopic gastric sleeve
  Laparoscopic gastric sleeve
• Процедура Gastric Banding
  Gastric Banding
• Процедура Multidisciplinary lifstyle intervention
  Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
• Процедура Roux-en-Y Bypass
  Roux-en-Y Bypass

Первичные конечные точки

• Body weight loss [Срок оценки: Every 6 months for a period of 3 years]

Вторичные конечные точки (8)

• Quality of life [Срок оценки: Every 6 months for a period of 3 years]
• Physical examination [Срок оценки: Every 6 months for a period of 3 years]
• Laboratory analysis [Срок оценки: Every 6 months for a period of 3 years]
• Vitamins/micronutrients [Срок оценки: Every 3-6 months for a period of maximal 3 years]
• Metabolomics, and Microflora analysis [Срок оценки: Every 3-6 months for a period of maximal 3 years]
• Liver fat [Срок оценки: Every 6 months for a period of 3 years]
• gut permeability [Срок оценки: Every 6 months for a period of 3 years]
• peripheral blood lipopolysaccharide concentrations [Срок оценки: Every 6 months for a period of 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 3 центра

• University of Heidelberg — Heidelberg
• University of Hohenheim — Stuttgart
• University of Tübingen — Tübingen

Публикации

• 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. PMID 28049662
• 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. PMID 25710027
• 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. PMID 22657586
• 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. PMID 22403000

Идентификаторы

NCT: NCT01344525 · OGIT-FKZ01GI0843

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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