ObesityAdipFollowupNCT04375371
Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients
A study testing Bariatric surgery in people with Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2020to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: 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.
Read more
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
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric surgery |
| Obese patients without a bariatric surgery | No intervention | Obese patients who have not undergone bariaric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: On average 11 years after baseline assessment (previous study).
Secondary outcomes (8)
Change in body weight
Effect of bariatric surgery versus no surgery on body weight assessed by calculating BMI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On average 11 years after baseline assessment (previous study).
Occurence of diabetic complications - retinopathy
Occurence of diabetes complications: retinopathy assessed by retinal examination
Measured: 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
Measured: 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.
Measured: On average 11 years after baseline assessment (previous study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start27 Jan 2020
- Primary completion20 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wagner, PD Dr., Principal investigator, University of Tuebingen, Department of Internal Medicine IV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375371
- Sponsor's protocol ID
- 338/2019BO1
- Acronym
- AdipFollowup
- Status last verified
- Nov 2020
- First submitted
- 18 Oct 2019
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klinische Und Metabolische Charakterisierung Der Langzeitverläufe Von Adipositas-Patienten Mit Vergleich Von Bariatrisch Operierten zu Nicht Operierten Patienten
- ClinicalTrials.gov ID
- NCT04375371
- Acronym / sponsor ID
- AdipFollowup / 338/2019BO1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients who have received a bariatric surgery | Active comparator | Procedure: Bariatric surgeryObese patients who have undergone a bariaric surgery as part of routine clinical management within the indication of this intervention. |
| Obese patients without a bariatric surgery | No intervention | –Obese patients who have not undergone bariaric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryObese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention. | Procedure or surgery | Obese patients who have received a bariatric surgery |
Primary outcome
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).
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).
8 secondary outcomes
Change in body weight
Time frame: Baseline (previous study) and after an average of 11 year (follow-up visit)
Change in body fat mass
Time frame: Baseline (previous study) and after an average of 11 year (follow-up visit)
Change in fat free mass
Time frame: Baseline (previous study) and after an average of 11 year (follow-up visit)
Change in insulin sensitivity
Time frame: Baseline (previous study) and after an average of 11 year (follow-up visit)
Occurence of diabetic complications - nephropathy
Time frame: On average 11 years after baseline assessment (previous study).
Occurence of diabetic complications - retinopathy
Time frame: On average 11 years after baseline assessment (previous study).
Occurence of diabetic complications - neuropathy
Time frame: On average 11 years after baseline assessment (previous study).
Occurence of macrovascular complications
Time frame: On average 11 years after baseline assessment (previous study).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wagner, PD Dr. principal investigator
University of Tuebingen, Department of Internal Medicine IV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Obesity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diabetes (time frame: On average 11 years after baseline assessment (previous study).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.