Clinical trial NCT01086111: The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient
Official title: Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Morbid Obesity
Keywords: type 2 diabetes
gastric bypass
sleeve gastrectomy
clamp study
weight loss surgery
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes patients with a BMI \> 35kg/m²

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


Eligibility 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.

Primary outcomes:
measure: insulin sensitivity and beta cell function
timeFrame: 3 weeks
Secondary outcomes:
measure: changes in plasma levels of gut hormones and inflammation markers
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, gasthuisberg
Study officials:
References: