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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| Karl-Olga-Krankenhaus Stuttgart | UNKNOWN |
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The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.
Previous studies have shown, that laparoscopic Roux-en-Y gastric bypass (LRYGB), and also laparoscopic sleeve gastrectomy (LSG) leed to a significant improvement of glucose metabolism and in many cases to a complete remission of diabetes type II in obese patients. It is still unclear which mechanisms underlie these changes. Since the positive effects of bariatric surgery have been investigated within few days after surgical intervention, before significant weight loss has been achieved, the caloric restriction has been discussed as a possible mechanism.
The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients. Therefore, the investigator will examine obese patients with diabetes type II or impaired glucose metabolism regarding possible metabolic changes within few days after bariatric surgery (LSG or LRYGB) or caloric restriction only.
Group I: Patients undergoing LSG; Group II: Patients undergoing LRYGB; Group III (Control group): Patients undergoing caloric restriction;
Dietetic, anthropometric, metabolic and hormonal parameters will be measured. Primary outcome marker is the insulin sensitivity according to Matsuda (MISI).
The project is a prospective, controlled study. Study examinations will be performed before intervention, and one, two, three, four and five days after (start of) intervention, as well after one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSG group | Experimental | Laparoscopic sleeve gastrectomy |
|
| LRYGB group | Experimental | Laparoscopic Roux-en-Y gastric bypass |
|
| Control group | Other | Caloric restriction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Other | The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of insulin | Blood insulin is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index | Within 5 days after surgery or 5 days after start of caloric restriction |
| Change of blood glucose | Blood glucose is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index | Within 5 days after surgery or 5 days after start of caloric restriction |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes regarding markers of glucose metabolism | HbA1c, C-Peptid, insulin and fasting glucose | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of body weight | Within 5 days after surgery or 5 days after start of caloric restriction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Schweinlin | Contact | +4971145924880 | anna.schweinlin@uni-hohenheim.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephan C. Bischoff, Prof. | Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany | Study Chair |
| Alfred Königsrainer, Prof. | Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hohenheim | Recruiting | Stuttgart | Germany |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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|
| Laparoscopic Roux-en-Y gastric bypass | Other | The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food. |
|
| Caloric restriction diet | Other | Patients of the control group do not undergo surgical treatment. They undergo a caloric restriction diet for 5 days. This diet is adapted to the postoperative diet of the patients included in the two other groups. |
|
| easy digestible diet | Other |
|
| Changes of blood lipids | High density lipoprotein, low density lipoprotein, triglycerides, free fatty acids | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes concerning the intake of calories and nutrients | Measured by using nutritional protocols | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of gastrointestinal hormones | Glucagon-like peptide-1, Ghrelin, Glucose-dependent insulinotropic peptide | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of adiponectin | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of bile acids | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of gut microbiota composition | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of body height | Within 5 days after surgery or 5 days after start of caloric restriction |
| Changes of body composition | measured by Body Impedance Analysis | Within 5 days after surgery or 5 days after start of caloric restriction |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |