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

June 23, 2017 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
RYGB
RYGB-operated type 2 diabetic patients
non-RYGB
non-RYGB-operated type 2 diabetic controls

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry
Time Frame: Maximum follow-up is 121 months (january 2006-february 2016)
Maximum follow-up is 121 months (january 2006-february 2016)
Number of patients with urine albumin/creatinin< 30 mg/g
Time Frame: Maximum follow-up is 121 months (january 2006-february 2016)
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
Time Frame: From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months
From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Lene R Madsen, MD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11092015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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