Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients
- Conditions
- Obesity
- Interventions
- Procedure: Bariatric surgery
- Registration Number
- NCT04375371
- Lead Sponsor
- University Hospital Tuebingen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obese patients who have received a bariatric surgery Bariatric surgery Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention.
- Primary Outcome Measures
Name Time Method 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).
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).
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
Occurence of diabetic complications - nephropathy On average 11 years after baseline assessment (previous study). Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.
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
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.
Trial Locations
- Locations (1)
University of Tuebingen, Department of Internal Medicine IV
🇩🇪Tübingen, Germany