Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
NCT ID: NCT02729246
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2014-10-31
2020-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
No interventions assigned to this group
Surgery Group
The patients in this group will undergo Laparoscopic Gastric Bypass surgery
Laparoscopic Gastric Bypass
Interventions
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Laparoscopic Gastric Bypass
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.
Exclusion Criteria
* Known or suspected history of significant drug abuse.
* History of alcohol abuse or excessive intake of alcohol as judged by investigator.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
* Sleep apnea
* Any previous serious cardiovascular event, stroke , acute myocardial infarction.
* Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) \<60, foot ulcers, symptomatic neuropathy
* Medications within 3 months : Insulin, Thiazolidinediones
* Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
* Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
18 Years
60 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Jan Eriksson, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Sciences, Clinical diabetology and metabolism
Locations
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Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism
Uppsala, , Sweden
Countries
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References
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Almby KE, Katsogiannos P, Pereira MJ, Karlsson FA, Sundbom M, Wiklund U, Kamble PG, Eriksson JW. Time Course of Metabolic, Neuroendocrine, and Adipose Effects During 2 Years of Follow-up After Gastric Bypass in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4049-e4061. doi: 10.1210/clinem/dgab398.
Katsogiannos P, Randell E, Sundbom M, Rosenblad A, Eriksson JW, Leksell J. Quality of life after gastric bypass surgery in patients with type 2 diabetes: patients' experiences during 2 years of follow-up. Diabetol Metab Syndr. 2020 Oct 12;12:90. doi: 10.1186/s13098-020-00597-1. eCollection 2020.
Katsogiannos P, Kamble PG, Boersma GJ, Karlsson FA, Lundkvist P, Sundbom M, Pereira MJ, Eriksson JW. Early Changes in Adipose Tissue Morphology, Gene Expression, and Metabolism After RYGB in Patients With Obesity and T2D. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2601-2613. doi: 10.1210/jc.2018-02165.
Other Identifiers
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Dnr 2014/255
Identifier Type: -
Identifier Source: org_study_id
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