Obesity Clinical Trial
Official title:
Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients: Register-based and Clinical Follow-up Studies
This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular complications such as nephropathy and retinopathy. Finally, the study provides insight into the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota diversity and bile acid levels.
One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric
bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM
patients, matched on gender, age, presurgical body mass index, and diabetes duration.
The clinical follow-up consists of a physiological check-up, a thorough paraclinical
work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone
mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples
(microbiota), ophthalmological examination including retina photo, and a questionaire.
More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19
and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part
of the patients.
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