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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Hospital, Gasthuisberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01086111
First received: March 10, 2010
Last updated: March 11, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • insulin sensitivity and beta cell function [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 30
Study Start Date: February 2010
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086111

Contacts
Contact: Matthias AD Lannoo, MD 003216340595 matthias.lannoo@uzleuven.be

Locations
Belgium
University Hospitals Leuven, gasthuisberg Recruiting
Leuven, Belgium, 3000
Principal Investigator: matthias AD Lannoo, MD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

No publications provided

Responsible Party: Matthias lannoo, MD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01086111     History of Changes
Other Study ID Numbers: S51169
Study First Received: March 10, 2010
Last Updated: March 11, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Gasthuisberg:
type 2 diabetes
gastric bypass
sleeve gastrectomy
clamp study
weight loss surgery

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014