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NCT Number: NCT02625649

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Nephropathies Diabetic Nephropathy Diabetic Retinopathy Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Retinal Diseases Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with HbA1c<48 mmol/mol.

    Time frame: Maximum follow-up is 121 months (january 2006-february 2016)

Secondary outcomes

  1. 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)

  2. Number of patients with urine albumin/creatinin< 30 mg/g

    Time frame: Maximum follow-up is 121 months (january 2006-february 2016)

  3. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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