Obesity
Conditions
Brief summary
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.
Interventions
PROCEDUREBariatric surgery
Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in the study Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung
Exclusion criteria
* BMI \< 35 kg/m2 at start of the previous study * Women during pregnancy and lactation * Patients who are unable to give their consent * Patients who have undergone surgery within the last 3 months * acute disease or infection within the last 4 months * HIV- or hepatitis B/C-positive * for biopsy of fat tissue: known coagulation disorder or PTT or INR out of reference range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diabetes | On average 11 years after baseline assessment (previous study). | Diabetes mellitus as determined by HbA1c, fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test). |
| Incidence of prediabetes | On average 11 years after baseline assessment (previous study). | Prediabetes as determined by fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat mass | Baseline (previous study) and after an average of 11 year (follow-up visit) | Effect of bariatric surgery versus no surgery on body fat mass assessed by bioelectric impedance analysis. |
| Change in fat free mass | Baseline (previous study) and after an average of 11 year (follow-up visit) | Effect of bariatric surgery versus no surgery on fat free (kg) mass assessed by bioelectric impedance analysis. |
| Change in insulin sensitivity | Baseline (previous study) and after an average of 11 year (follow-up visit) | Effect of bariatric surgery versus no surgery on insulin sensitivity assessed by 75g oral glucose tolerance test. |
| Occurence of diabetic complications - retinopathy | On average 11 years after baseline assessment (previous study). | Occurence of diabetes complications: retinopathy assessed by retinal examination |
| Occurence of diabetic complications - neuropathy | On average 11 years after baseline assessment (previous study). | Occurence of diabetes complications: neuropathy assessed by Michigan-neuropathy screening tool |
| Occurence of macrovascular complications | On average 11 years after baseline assessment (previous study). | Occurence of manifestations of coronary artery disease (myocardial infarction, angina pectoris) or stroke or peripheral artery disease. |
| Occurence of diabetic complications - nephropathy | On average 11 years after baseline assessment (previous study). | Occurence of diabetes complications: nephropathy measured as urine microalbuminuria. |
| Change in body weight | Baseline (previous study) and after an average of 11 year (follow-up visit) | Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurene of depressions | On average 11 years after baseline assessment (previous study). | 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). |
| impulsivity measurement | 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). |
Countries
Germany
Outcome results
None listed