Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients

Obesity Clinical Trial

— AdipFollowup  

Official title:

Klinische Und Metabolische Charakterisierung Der Langzeitverläufe Von Adipositas-Patienten Mit Vergleich Von Bariatrisch Operierten zu Nicht Operierten Patienten

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375371
• Other study ID #: 338/2019BO1
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: November 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 23, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Bariatric surgery
Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	impulsivity measurement	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).
Primary	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).
Primary	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).
Secondary	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)
Secondary	Change in body fat mass	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)
Secondary	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)
Secondary	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)
Secondary	Occurence of diabetic complications - nephropathy	Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.	On average 11 years after baseline assessment (previous study).
Secondary	Occurence of diabetic complications - retinopathy	Occurence of diabetes complications: retinopathy assessed by retinal examination	On average 11 years after baseline assessment (previous study).
Secondary	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).
Secondary	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).