An interventional study of Bariatric surgery in Obesity, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 117 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention.
Procedure: Bariatric surgery
Obese patients who have not undergone bariaric surgery.
Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
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).
Time frame: 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).
Time frame: On average 11 years after baseline assessment (previous study).
Change in body weight
Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI.
Time frame: Baseline (previous study) and after an average of 11 year (follow-up visit)
Change in body fat mass
Effect of bariatric surgery versus no surgery on body fat mass assessed by bioelectric impedance analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On average 11 years after baseline assessment (previous study).
Occurence of diabetic complications - retinopathy
Occurence of diabetes complications: retinopathy assessed by retinal examination
Time frame: 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
Time frame: 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.
Time frame: On average 11 years after baseline assessment (previous study).
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).
Time frame: On average 11 years after baseline assessment (previous study).
impulsivity measurement
Impulsivity assessed by the Barratt Impulsiveness Scale-15 (BIS-15) questionnaire (minimum value:15, maximum value: 60; higher score indicate higher impulsivity).
Time frame: On average 11 years after baseline assessment (previous study).
Plan to share: No
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University Hospital Tuebingen