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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Morbid Obesity

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

type 2 diabetes patients with a BMI > 35kg/m²

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in plasma levels of gut hormones and inflammation markers	3 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Gasthuisberg

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 12, 2010

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: type 2 diabetes; sleeve gastrectomy; gastric bypass; weight loss surgery; clamp study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
• Other Study ID Numbers: S51169