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The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01086111
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Matthias Lannoo, University Hospital, Gasthuisberg

Brief Summary:

Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery.

The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively.

Aims & methodology:

Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function.

Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative.

To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared

Condition or disease
Type 2 Diabetes Morbid Obesity

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass
Study Start Date : February 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

type 2 diabetes patient receiving a protein sparing diet
sleeve gastrectomy
type 2 diabetes patient receiving a gastric bypass
type 2 diabetes patient receiving a gastric bypass

Primary Outcome Measures :
  1. insulin sensitivity and beta cell function [ Time Frame: 3 weeks ]
    insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques.

Secondary Outcome Measures :
  1. changes in plasma levels of gut hormones and inflammation markers [ Time Frame: 3 weeks ]

Biospecimen Retention:   Samples With DNA
blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 2 diabetes patients with a BMI > 35kg/m²

Inclusion Criteria:

  • Female or male subjects aged 18 to 65
  • BMI > 35 kg/m2
  • Subject is capable and willing to give informed consent.
  • In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of 199112.
  • Patient suffers from type 2 diabetes necessitating insulin therapy.
  • Subject is a non-smoker for at least 6 months prior to study start.
  • Female patients of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the screening visit. Patients using hormonal contraception should use a barrier method in addition from screening visit until their next normal period following the end of the study.
  • Female patients of non-child bearing potential defined as:

    • Post-menopausal females, being amenorrhoeic for at least 1 year
    • Pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.

Exclusion Criteria:

  • Female patient is pregnant or breastfeeding.
  • BMI < 35 kg/m2
  • Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor…)
  • Patient suffers from type 1 diabetes, MODY or LADA
  • Patient has undergone previous surgical procedure for weight loss
  • Patient is considered ASA 4 or more according to the ASA physical status classification system of the American Society of Anesthesiologists.
  • Patient suffers from liver cirrhosis
  • Patient uses steroids
  • Patient uses cyclosporin
  • Recent (<30 days) or simultaneous participation in another clinical trial.
  • Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01086111

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University Hospitals Leuven, gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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Responsible Party: Matthias Lannoo, medical doctor, University Hospital, Gasthuisberg Identifier: NCT01086111    
Other Study ID Numbers: S51169
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by Matthias Lannoo, University Hospital, Gasthuisberg:
type 2 diabetes
gastric bypass
sleeve gastrectomy
clamp study
weight loss surgery
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight