Clinical trial NCT04375371: Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients
Official title: Klinische Und Metabolische Charakterisierung Der Langzeitverläufe Von Adipositas-Patienten Mit Vergleich Von Bariatrisch Operierten zu Nicht Operierten Patienten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Incidence of diabetes
timeFrame: On average 11 years after baseline assessment (previous study).
measure: Incidence of prediabetes
timeFrame: On average 11 years after baseline assessment (previous study).
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (previous study) and after an average of 11 year (follow-up visit)
measure: Change in body fat mass
timeFrame: Baseline (previous study) and after an average of 11 year (follow-up visit)
measure: Change in fat free mass
timeFrame: Baseline (previous study) and after an average of 11 year (follow-up visit)
measure: Change in insulin sensitivity
timeFrame: Baseline (previous study) and after an average of 11 year (follow-up visit)
measure: Occurence of diabetic complications - nephropathy
timeFrame: On average 11 years after baseline assessment (previous study).
measure: Occurence of diabetic complications - retinopathy
timeFrame: On average 11 years after baseline assessment (previous study).
measure: Occurence of diabetic complications - neuropathy
timeFrame: On average 11 years after baseline assessment (previous study).
measure: Occurence of macrovascular complications
timeFrame: On average 11 years after baseline assessment (previous study).
Other outcomes:
measure: Occurene of depressions
timeFrame: On average 11 years after baseline assessment (previous study).
measure: impulsivity measurement
timeFrame: On average 11 years after baseline assessment (previous study).
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
affiliation: University of Tuebingen, Department of Internal Medicine IV
name: Robert Wagner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: