Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients (AdipFollowup)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by

About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
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
Sites / Locations
- University of Tuebingen, Department of Internal Medicine IV
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Obese patients who have received a bariatric surgery
Obese patients without a bariatric surgery
Arm Description
Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention.
Obese patients who have not undergone bariaric surgery.
Outcomes
Primary Outcome Measures
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).
Incidence of prediabetes
Prediabetes as determined by fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test).
Secondary Outcome Measures
Change in body weight
Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI.
Change in body fat mass
Effect of bariatric surgery versus no surgery on body fat mass assessed by bioelectric impedance analysis.
Change in fat free mass
Effect of bariatric surgery versus no surgery on fat free (kg) mass assessed by bioelectric impedance analysis.
Change in insulin sensitivity
Effect of bariatric surgery versus no surgery on insulin sensitivity assessed by 75g oral glucose tolerance test.
Occurence of diabetic complications - nephropathy
Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.
Occurence of diabetic complications - retinopathy
Occurence of diabetes complications: retinopathy assessed by retinal examination
Occurence of diabetic complications - neuropathy
Occurence of diabetes complications: neuropathy assessed by Michigan-neuropathy screening tool
Occurence of macrovascular complications
Occurence of manifestations of coronary artery disease (myocardial infarction, angina pectoris) or stroke or peripheral artery disease.
Full Information
NCT ID
NCT04375371
First Posted
October 18, 2019
Last Updated
June 4, 2021
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04375371
Brief Title
Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients
Acronym
AdipFollowup
Official Title
Klinische Und Metabolische Charakterisierung Der Langzeitverläufe Von Adipositas-Patienten Mit Vergleich Von Bariatrisch Operierten zu Nicht Operierten Patienten
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese patients who have received a bariatric surgery
Arm Type
Active Comparator
Arm Description
Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention.
Arm Title
Obese patients without a bariatric surgery
Arm Type
No Intervention
Arm Description
Obese patients who have not undergone bariaric surgery.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
Primary Outcome Measure Information:
Title
Incidence of diabetes
Description
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).
Title
Incidence of prediabetes
Description
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).
Secondary Outcome Measure Information:
Title
Change in body weight
Description
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)
Title
Change in body fat mass
Description
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)
Title
Change in fat free mass
Description
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)
Title
Change in insulin sensitivity
Description
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)
Title
Occurence of diabetic complications - nephropathy
Description
Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.
Time Frame
On average 11 years after baseline assessment (previous study).
Title
Occurence of diabetic complications - retinopathy
Description
Occurence of diabetes complications: retinopathy assessed by retinal examination
Time Frame
On average 11 years after baseline assessment (previous study).
Title
Occurence of diabetic complications - neuropathy
Description
Occurence of diabetes complications: neuropathy assessed by Michigan-neuropathy screening tool
Time Frame
On average 11 years after baseline assessment (previous study).
Title
Occurence of macrovascular complications
Description
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).
Other Pre-specified Outcome Measures:
Title
Occurene of depressions
Description
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).
Title
impulsivity measurement
Description
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wagner, PD Dr.
Organizational Affiliation
University of Tuebingen, Department of Internal Medicine IV
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tuebingen, Department of Internal Medicine IV
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients
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