Morbid Obesity, Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, gastric bypass, sleeve gastrectomy, clamp study, weight loss surgery
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
Interventions
None listed
Sponsors
University Hospital, Gasthuisberg
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin sensitivity and beta cell function | 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
| Measure | Time frame |
|---|---|
| changes in plasma levels of gut hormones and inflammation markers | 3 weeks |
Countries
Belgium
Outcome results
None listed