Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients: Register-based and Clinical Follow-up Studies

Conditions
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Obesity, Type 2 Diabetes Mellitus, Diabetic Retinopathy, Diabetic Nephropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable type 2 diabetes mellitus speaks and understands Danish presents written concent cases must be Roux-en-Y operated between 2006-2011. Exclusion Criteria: Converted Roux-en-Y chronic inflammatory bowel disease ischemic heart disease liver disease cholecystectomy. Controls can not be bariatric operated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RYGB<br>RYGB-operated type 2 diabetic patients | |
| non-RYGB<br>non-RYGB-operated type 2 diabetic controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with HbA1c<48 mmol/mol. |  | Maximum follow-up is 121 months (january 2006-february 2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry |  | Maximum follow-up is 121 months (january 2006-february 2016) | 
| Number of patients with urine albumin/creatinin< 30 mg/g |  | Maximum follow-up is 121 months (january 2006-february 2016) | 
| Number of patients with two-step change from preoperative level on the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) scale |  | From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-Y gastric bypass, obesity, type 2 diabetes mellitus, diabetic nephropathy, diabetic retinopathy