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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02625649

Enrollment

148

Registered

2015-12-09

Start date

2016-01-31

Completion date

2017-06-30

Last updated

2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Roux-en-Y gastric bypass, obesity, type 2 diabetes mellitus, diabetic nephropathy, diabetic retinopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Denmark

Outcome results