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

NCT04375371 | Completed

• 1 other identifier: 338/2019BO1
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in body weight

  Baseline (previous study) and after an average of 11 year (follow-up visit)

• Change in body fat mass

  Baseline (previous study) and after an average of 11 year (follow-up visit)

• Change in fat free mass

  Baseline (previous study) and after an average of 11 year (follow-up visit)

• Change in insulin sensitivity

  Baseline (previous study) and after an average of 11 year (follow-up visit)

• Occurence of diabetic complications - nephropathy

  On average 11 years after baseline assessment (previous study).

Other Outcomes (2)

• Occurene of depressions

  On average 11 years after baseline assessment (previous study).

• impulsivity measurement

  On average 11 years after baseline assessment (previous study).

Study Arms (2)

Obese patients who have received a bariatric surgery

ACTIVE COMPARATOR

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 without a bariatric surgery

NO INTERVENTION

Obese patients who have not undergone bariaric surgery.

Interventions

Bariatric surgery PROCEDURE

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

Obese patients who have received a bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Robert Wagner, PD Dr.

  University of Tuebingen, Department of Internal Medicine IV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: May 5, 2020
• Study Start: January 27, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 23, 2020
• Last Updated: June 7, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)