Clinical trial NCT02625649: Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Obesity
Diabetic Retinopathy
Diabetic Nephropathy
Keywords: Roux-en-Y gastric bypass
obesity
type 2 diabetes mellitus
diabetic nephropathy
diabetic retinopathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: Type 2 diabetes mellitus patients living in Central Denmark region that have undergone Roux-en-Y gastric bapass between 2006-2011.

Controls: Type 2 diabetes mellitus patients living in Central Denmark region, non-RYGB-operated

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with HbA1c<48 mmol/mol.
timeFrame: Maximum follow-up is 121 months (january 2006-february 2016)
Secondary outcomes:
measure: Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry
timeFrame: Maximum follow-up is 121 months (january 2006-february 2016)
measure: Number of patients with urine albumin/creatinin< 30 mg/g
timeFrame: Maximum follow-up is 121 months (january 2006-february 2016)
measure: Number of patients with two-step change from preoperative level on the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) scale
timeFrame: From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lene R Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen LR, Bek T, Richelsen B. Diabetic retinopathy in people with Type 2 diabetes and obesity treated by Roux-en-Y gastric bypass compared with non-operated controls: with focus on the role of diabetes remission in a cross-sectional and a 6-year follow-up study. Diabet Med. 2019 Apr;36(4):457-464. doi: 10.1111/dme.13876. Epub 2018 Dec 26.