Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 3:28 PM
Study NCT ID:
NCT01477957
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2011-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2011-11-13', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy metabolism', 'timeFrame': '5 years', 'description': 'whole body substrate oxidation, ex vivo mitochondrial function via measurement of high resolution respirometry and in vivo mitochondrial function via measurement of ATP production'}], 'secondaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '5 years', 'description': 'body weight and body composition before and after bariatric surgery'}, {'measure': 'Insulin sensitivity', 'timeFrame': '5 years', 'description': 'Whole body glucose uptake and endogenous glucose production as measure of skeletal muscle and hepatic insulin sensitivity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weight loss after bariatric surgery', 'Insulin sensitivity', 'insulin resistance'], 'conditions': ['Obesity', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '25955209', 'type': 'BACKGROUND', 'citation': 'Koliaki C, Szendroedi J, Kaul K, Jelenik T, Nowotny P, Jankowiak F, Herder C, Carstensen M, Krausch M, Knoefel WT, Schlensak M, Roden M. Adaptation of hepatic mitochondrial function in humans with non-alcoholic fatty liver is lost in steatohepatitis. Cell Metab. 2015 May 5;21(5):739-46. doi: 10.1016/j.cmet.2015.04.004.'}, {'pmid': '39218222', 'type': 'DERIVED', 'citation': 'Kahl S, Strassburger K, Pacini G, Trinks N, Pafili K, Mastrototaro L, Dewidar B, Sarabhai T, Trenkamp S, Esposito I, Schlensak M, Granderath FA, Roden M. Dysglycemia and liver lipid content determine the relationship of insulin resistance with hepatic OXPHOS capacity in obesity. J Hepatol. 2025 Mar;82(3):417-426. doi: 10.1016/j.jhep.2024.08.012. Epub 2024 Aug 31.'}, {'pmid': '38122893', 'type': 'DERIVED', 'citation': 'Sarabhai T, Kahl S, Gancheva S, Mastrototaro L, Dewidar B, Pesta D, Ratter-Rieck JM, Bobrov P, Jeruschke K, Esposito I, Schlensak M, Roden M. Loss of mitochondrial adaptation associates with deterioration of mitochondrial turnover and structure in metabolic dysfunction-associated steatotic liver disease. Metabolism. 2024 Feb;151:155762. doi: 10.1016/j.metabol.2023.155762. Epub 2023 Dec 19.'}, {'pmid': '35988689', 'type': 'DERIVED', 'citation': 'Pafili K, Kahl S, Mastrototaro L, Strassburger K, Pesta D, Herder C, Putzer J, Dewidar B, Hendlinger M, Granata C, Saatmann N, Yavas A, Gancheva S, Heilmann G, Esposito I, Schlensak M, Roden M. Mitochondrial respiration is decreased in visceral but not subcutaneous adipose tissue in obese individuals with fatty liver disease. J Hepatol. 2022 Dec;77(6):1504-1514. doi: 10.1016/j.jhep.2022.08.010. Epub 2022 Aug 19.'}, {'pmid': '29602794', 'type': 'DERIVED', 'citation': 'Apostolopoulou M, Gordillo R, Koliaki C, Gancheva S, Jelenik T, De Filippo E, Herder C, Markgraf D, Jankowiak F, Esposito I, Schlensak M, Scherer PE, Roden M. Specific Hepatic Sphingolipids Relate to Insulin Resistance, Oxidative Stress, and Inflammation in Nonalcoholic Steatohepatitis. Diabetes Care. 2018 Jun;41(6):1235-1243. doi: 10.2337/dc17-1318. Epub 2018 Mar 30.'}], 'seeAlsoLinks': [{'url': 'https://ddz.de/studien/baria-ddz-studie/', 'label': 'Homepage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery\n2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3)\n3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is associated with the degree of liver inflammation', 'detailedDescription': 'Insulin resistance strongly relates to ectopic lipid deposition in skeletal muscle and the liver, which correlate with insulin resistance. Lipid metabolites accumulating in skeletal muscle and the liver are thought to impair insulin signalling and thereby reduce glucose uptake and glycogen storage. Insulin resistant humans frequently present with decreased mitochondrial function in skeletal muscle which might contribute to lipid accumulation and the development of insulin resistance. Metabolic dysfunction-associated steatotic liver disease comprises steatosis, steatohepatitis and cirrhosis. MASLD correlates with insulin resistance, increased risk for cardiovascular diseases and type 2 diabetes. The mechanisms leading from steatosis to steatohepatitis and insulin resistance in the liver are yet unclear. Bariatric surgery aims at profound reduction of body weight. Also, it frequently and rapidly leads to normalization of glucose tolerance even before the onset of body weight reduction. The underlying mechanisms are yet unclear. In this study we aim to explore the mechanisms underlying the onset of insulin resistance and steatohepatitis in patients with steatosis and to identify the mechanisms leading to improved glucose tolerance in humans after bariatric surgery. We test the following hypotheses: increased lipid availability leads to (i) increased lipid oxidation and oxidative stress (ii) accumulation of lipid metabolites that impair insulin signalling (iii) bariatric surgery improves insulin sensitivity by increasing lipid oxidation.\n\nThis study will contribute to the understanding of MASLD and will help to identify new targets for the therapy of diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with obesity and various stages of MASLD, that qualify for bariatric surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 20 years- ≤ 70 years\n* BMI 20- 25 kg/m 2 normal- weight group\n* BMI 35- 39,9 kg/m 2 (Obesity grade 2)\n* BMI \\>40 kg/m 2 (Obesity grade 3)\n\nExclusion Criteria:\n\n* Acute illness 2 weeks before start of examination\n* Autoimmune or Immune disorder diseases (Leukozyten \\< 5000/µl\n* Renal insufficiency (Kreatin \\> 1,5 mg/dl)\n* Heart disease, condition after heart attack\n* Anemia (Hb \\<12g/l, controlled before every day of examination) or blood donations 4weeks before examination.\n* Participation in another trial within the last 2 weeks\n* Pharmacological- immunotherapy (Cortisol, Antihistaminika, ASS)\n* Thyroid disorders\n* Glitazone Therapy\n* Pregnancy, Lactation, Menstruation\n* Smoking cigarettes, Alcohol- and drug abuse\n* Psychiatric disorders\n* Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C\n* Liver disease, which are not caused by non- alcoholic steato- hepatitis\n* Working on night shifts or irregular rhythm of night- day\n* Impaired wound healing or clotting disorders\n* Allergic reaction to local anesthetics\n* Malignant cancer'}, 'identificationModule': {'nctId': 'NCT01477957', 'acronym': 'BARIA-DDZ', 'briefTitle': 'The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism in Obesity Grade 2 -3', 'orgStudyIdInfo': {'id': 'BARIA-DDZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery', 'description': 'bariatric surgery', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'otherNames': ['bariatric surgery'], 'description': 'biliopancreatic diversion, gastric banding, gastric sleeve resection', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Roden, Prof., MD', 'role': 'CONTACT', 'email': 'michael.roden@ddz.de', 'phone': '0049211-3382', 'phoneExt': '201'}, {'name': 'Sabine Kahl, MD', 'role': 'CONTACT', 'email': 'sabine.kahl@ddz.de', 'phone': '0049211-3382', 'phoneExt': '698'}], 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Sabine Kahl, MD', 'role': 'CONTACT', 'email': 'sabine.kahl@ddz.de', 'phone': '0049211-3382', 'phoneExt': '698'}], 'overallOfficials': [{'name': 'Michael Roden, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dep.of General-, Visceral- and Pediatric Surgery, HHU, Duesseldorf, Germany', 'class': 'UNKNOWN'}, {'name': 'Dep.for Metabolic Diseases, HHU, Duesseldorf, Germany', 'class': 'UNKNOWN'}, {'name': 'Hospital Neuwerk, Mönchengladbach, Duesseldorf, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}