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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01086111
First Posted: March 12, 2010
Last Update Posted: December 4, 2015
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.
Information provided by (Responsible Party):
Matthias Lannoo, University Hospital, Gasthuisberg
  Purpose

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
Type 2 Diabetes Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass

Further study details as provided by Matthias Lannoo, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • 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:
  • changes in plasma levels of gut hormones and inflammation markers [ Time Frame: 3 weeks ]

Biospecimen Retention:   Samples With DNA
blood samples

Enrollment: 30
Study Start Date: February 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
PMSF
type 2 diabetes patient receiving a protein sparing diet
sleeve gastrectomy
type 2 diabetes patient receiving a gastric bypass
RYGBP
type 2 diabetes patient receiving a gastric bypass

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01086111


Locations
Belgium
University Hospitals Leuven, gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

Responsible Party: Matthias Lannoo, medical doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01086111     History of Changes
Other Study ID Numbers: S51169
First Submitted: March 10, 2010
First Posted: March 12, 2010
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms


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