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The long-term courses after bariatric surgery are not sufficiently known. Furthermore there is a heterogeneity in postoperative responses.
The aim of this study is to investigate the glycemic course (prediabetes, development of diabetes) of patients with obesity (BMI>=35 kg/m2) who had undergone bariatric surgery compared to patients with obesity who have not. A further aim is to investigate predictors of weight development, development of body composition and insulin sensitivity of patients who had undergone bariatric surgery compared to obesity patients who have not undergone bariatric surgery. The long-term courses after different surgical procedures (Roux-Y vs Sleeve) will be compared.
In this study 300 patients with obesity who had been metabolically characterized in a previous study will be recruited.
These patients are examined (medical history, physical examination including ECG, BIA, weight, height) and metabolically characterized.
Participants without diabetes undergo a glucose tolerance test and fasting blood sampling will be performed in participants with diabetes. All patients complete questionnaires to activity, nutrition, life quality, impulsiveness, depression and eating behavior.
Randomly selected participants will be offered an abdominal fat tissue biopsy. When consent is given, this will be performed at least two days after the glucose tolerance test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients who have received a bariatric surgery | Active Comparator | Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention. |
|
| Obese patients without a bariatric surgery | No Intervention | Obese patients who have not undergone bariaric surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of diabetes | Diabetes mellitus as determined by HbA1c, fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test). | On average 11 years after baseline assessment (previous study). |
| Incidence of prediabetes | Prediabetes as determined by fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test). | On average 11 years after baseline assessment (previous study). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI. | Baseline (previous study) and after an average of 11 year (follow-up visit) |
| Change in body fat mass |
| Measure | Description | Time Frame |
|---|---|---|
| Occurene of depressions | Occurene of depressions as estimate of quality of life assessed by the BDI-II Beck's Depression Inventory (BDI-II) questionnaire (minimum value:0, maximum value: 63; higher score indicate more severe depressive symptoms). | On average 11 years after baseline assessment (previous study). |
| impulsivity measurement |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wagner, PD Dr. | University of Tuebingen, Department of Internal Medicine IV | 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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Effect of bariatric surgery versus no surgery on body fat mass assessed by bioelectric impedance analysis.
| Baseline (previous study) and after an average of 11 year (follow-up visit) |
| Change in fat free mass | Effect of bariatric surgery versus no surgery on fat free (kg) mass assessed by bioelectric impedance analysis. | Baseline (previous study) and after an average of 11 year (follow-up visit) |
| Change in insulin sensitivity | Effect of bariatric surgery versus no surgery on insulin sensitivity assessed by 75g oral glucose tolerance test. | Baseline (previous study) and after an average of 11 year (follow-up visit) |
| Occurence of diabetic complications - nephropathy | Occurence of diabetes complications: nephropathy measured as urine microalbuminuria. | On average 11 years after baseline assessment (previous study). |
| Occurence of diabetic complications - retinopathy | Occurence of diabetes complications: retinopathy assessed by retinal examination | On average 11 years after baseline assessment (previous study). |
| Occurence of diabetic complications - neuropathy | Occurence of diabetes complications: neuropathy assessed by Michigan-neuropathy screening tool | On average 11 years after baseline assessment (previous study). |
| Occurence of macrovascular complications | Occurence of manifestations of coronary artery disease (myocardial infarction, angina pectoris) or stroke or peripheral artery disease. | On average 11 years after baseline assessment (previous study). |
Impulsivity assessed by the Barratt Impulsiveness Scale-15 (BIS-15) questionnaire (minimum value:15, maximum value: 60; higher score indicate higher impulsivity). |
| On average 11 years after baseline assessment (previous study). |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |