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low recruitment
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Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric surgery | Experimental | Subjects undergoing laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central insulin sensitivity | Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo. | Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards. |
| Peripheral insulin sensitivity | Peripheral insulin sensitivity will be assessed by oral glucose tolerance test. | Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole body fat distribution | Body fat distribution will be assessed by MRI | Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards. |
| Liver fat content | Liver fat content will be assessed by MRS |
| Measure | Description | Time Frame |
|---|---|---|
| Liver, adipose tissue and muscle specimens | During surgery liver, subcutaneous and visceral adipose tissue and skeletal muscle will be collected. | At surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Heni, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tuebingen, Department of Internal Medicine IV | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards. |
| Metabolic rate | Metabolic rate will be assessed by indirect calorimetry | Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards. |
| Response to food cues | Food cues will be rated for palatability on a visual analogue scale | Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards. |
| Trail-making test | Trail-making test will be performed | Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards. |
| Hopkins-verbal learning test | Hopkins-verbal learning test will be performed | Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards. |
| Glucose tolerance | Glucose tolerance will be assessed by 75g oral glucose tolerance test. | Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards. |
| Insulin secretion | Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test. | Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards. |
| Weight loss | Body weight will be measured before and 6 months after surgery. | Weight loss before and 6 months after surgery. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |