Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients (AdipFollowup)

University Hospital Tuebingen

Status: Completed

Conditions: Obesity

Treatments: Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04375371

338/2019BO1

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Obese patients who have received a bariatric surgery

Active Comparator group

Description:

Obese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention.

Treatment:

Procedure: Bariatric surgery

Obese patients without a bariatric surgery

No Intervention group

Description:

Obese patients who have not undergone bariaric surgery.