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

Type 2 Diabetes Clinical Trial

Official title:

Mechanisms of Type 2 Diabetes Improvement, Besides Weightloss After Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086111
• Other study ID #: S51169
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: December 3, 2015
• Start date: February 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Morbid Obesity
• Obesity, Morbid
• Type 2 Diabetes

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity and beta cell function	insulin sensitivity and beta cell function changes 3 weeks after RYGB, sleeve gastrectomy and protein sparing diet using euglycaemic and hyperglycemic clamp techniques.	3 weeks	No
Secondary	changes in plasma levels of gut hormones and inflammation markers		3 weeks	No