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

NCT ID: NCT04375371

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2020-10-23

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Obese patients who have received a bariatric surgery

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

Group Type: ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type: PROCEDURE

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

Obese patients without a bariatric surgery

Obese patients who have not undergone bariaric surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bariatric surgery

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wagner, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Tuebingen, Department of Internal Medicine IV

Locations

University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Countries

Germany

Other Identifiers

338/2019BO1

Identifier Type: -

Identifier Source: org_study_id