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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in plasma levels of gut hormones and inflammation markers | 3 weeks |
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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:
Exclusion Criteria:
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type 2 diabetes patients with a BMI > 35kg/m²
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven, gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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blood samples
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |