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NCT Number: NCT04375371

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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

Primary outcomes

  1. Incidence of diabetes

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

    Diabetes mellitus as determined by HbA1c, fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test).

  2. Incidence of prediabetes

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

    Prediabetes as determined by fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test).

Secondary outcomes

  1. Change in body weight

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

    Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI.

  2. Change in body fat mass

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

    Effect of bariatric surgery versus no surgery on body fat mass assessed by bioelectric impedance analysis.

  3. Change in fat free mass

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

    Effect of bariatric surgery versus no surgery on fat free (kg) mass assessed by bioelectric impedance analysis.

  4. Change in insulin sensitivity

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

    Effect of bariatric surgery versus no surgery on insulin sensitivity assessed by 75g oral glucose tolerance test.

  5. Occurence of diabetic complications - nephropathy

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

    Occurence of diabetes complications: nephropathy measured as urine microalbuminuria.

  6. Occurence of diabetic complications - retinopathy

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

    Occurence of diabetes complications: retinopathy assessed by retinal examination

  7. Occurence of diabetic complications - neuropathy

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

    Occurence of diabetes complications: neuropathy assessed by Michigan-neuropathy screening tool

  8. Occurence of macrovascular complications

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

    Occurence of manifestations of coronary artery disease (myocardial infarction, angina pectoris) or stroke or peripheral artery disease.

Other outcomes

  1. Occurene of depressions

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

    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).

  2. impulsivity measurement

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

    Impulsivity assessed by the Barratt Impulsiveness Scale-15 (BIS-15) questionnaire (minimum value:15, maximum value: 60; higher score indicate higher impulsivity).

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: AdipFollowup

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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