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

Completed

• Conditions: Diabetic Retinopathy; Obesity; Type 2 Diabetes Mellitus; Diabetic Nephropathy

• Registration Number: NCT02625649
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Study Start: 2016-01
• Status Verified: 2016-10
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Capable
• type 2 diabetes mellitus
• speaks and understands Danish
• presents written concent
• cases must be Roux-en-Y operated between 2006-2011.

Read More

Exclusion Criteria

• Converted Roux-en-Y
• chronic inflammatory bowel disease
• ischemic heart disease
• liver disease
• cholecystectomy.

Controls can not be bariatric operated.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with HbA1c<48 mmol/mol.	Maximum follow-up is 121 months (january 2006-february 2016)

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Department of Enodocrinology and Internal Medicine, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark