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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Bariatric surgery

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • University of Tuebingen, Department of Internal Medicine IV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Bariatric surgery; Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
No Intervention: Obese patients without a bariatric surgery; Obese patients who have not undergone bariaric surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Occurence of diabetic complications - nephropathy	Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.	On average 11 years after baseline assessment (previous study).
Occurence of diabetic complications - retinopathy	Occurence of diabetes complications: retinopathy assessed by retinal examination	On average 11 years after baseline assessment (previous study).
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Robert Wagner, PD Dr., University of Tuebingen, Department of Internal Medicine IV

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 338/2019BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No