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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625649
• Other study ID #: 11092015
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: June 23, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Diabetic Retinopathy
• Kidney Diseases
• Obesity
• Retinal Diseases
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Denmark	Department of Enodocrinology and Internal Medicine, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with HbA1c<48 mmol/mol.		Maximum follow-up is 121 months (january 2006-february 2016)
Secondary	Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry		Maximum follow-up is 121 months (january 2006-february 2016)
Secondary	Number of patients with urine albumin/creatinin< 30 mg/g		Maximum follow-up is 121 months (january 2006-february 2016)
Secondary	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