Morbid ObesityNCT03176615
Meal-induced Thrombin Generation Before and After Gastric Bypass
A study testing Experimental diet in people with Morbid Obesity and Weight Loss, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Weight Loss
- What is being tested?
- Experimental diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2017to 30 Nov 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible for gastric bypass surgery
Who cannot join
- Use of anticoagulants, platelet inhibitors and oral contraceptives
- Known liver diseases, any malignant disorders, or known coagulation diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Jutland
Esbjerg, 6700
About this study
Official title: Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.
- Conditions
- Morbid Obesity, Weight Loss
- Being tested
- Experimental diet
- Keywords
- Gastric Bypass
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental dietDietary supplement
The intervention will run concurrently with the gastric bypass treatment at the hospital. The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cross-over Group 1) | Experimental | Subjects randomly assigned to two experimental diets. This arm will receive high-fat meals first, followed by a washout period of two-seven days and then low-fat meals. Receives: Dietary Supplement: Experimental diet |
| Group B (Cross-over Group 2) | Experimental | Subjects randomly assigned to two experimental diets. This arm will receive low-fat meals first, followed by a washout period of two-seven days and then high-fat meals. Receives: Dietary Supplement: Experimental diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial peak mean of prothrombin fragment 1+2 concentrations
Blood samples are collected after high-fat and low-fat meals on two study days.
Measured: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Secondary outcomes (2)
Postprandial peak mean of cardiovascular risk markers concentrations
Blood samples are collected after high-fat and low-fat meals on two study days.
Measured: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Laboratory tests of fecal samples
Bacterial components of fecal samples
Measured: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Sep 2017
- Primary completion1 Feb 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will consume a high-fat meal and a low-fat meal served seperately in a randomized order on two seperate days (two-seven days apart)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Line Espenhain Landgrebe, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Else Bladbjerg, M.Sc. PhD, Study chair, Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176615
- Sponsor's protocol ID
- HospitalSWJ
- Status last verified
- Nov 2021
- First submitted
- 29 May 2017
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal-induced Thrombin Generation in Obese Women and Men Before and After Gastric Bypass - a Model of Intentional Weight Loss
- ClinicalTrials.gov ID
- NCT03176615
- Acronym / sponsor ID
- HospitalSWJ
- Conditions
- Morbid Obesity, Weight Loss
- Keywords
- Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Jun 2017 (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 purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will consume a high-fat meal and a low-fat meal served seperately in a randomized order on two seperate days (two-seven days apart)
| Arm | Type | Receives |
|---|---|---|
| Group A (Cross-over Group 1) | Experimental | Dietary Supplement: Experimental dietSubjects randomly assigned to two experimental diets. This arm will receive high-fat meals first, followed by a washout period of two-seven days and then low-fat meals. |
| Group B (Cross-over Group 2) | Experimental | Dietary Supplement: Experimental dietSubjects randomly assigned to two experimental diets. This arm will receive low-fat meals first, followed by a washout period of two-seven days and then high-fat meals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible for gastric bypass surgery
Key exclusion criteria (2 listed)
- Use of anticoagulants, platelet inhibitors and oral contraceptives
- Known liver diseases, any malignant disorders, or known coagulation diseases
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 |
|---|---|---|
| Experimental dietThe intervention will run concurrently with the gastric bypass treatment at the hospital. The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass) | Dietary supplement | Group A (Cross-over Group 1), Group B (Cross-over Group 2) |
Primary outcome
Postprandial peak mean of prothrombin fragment 1+2 concentrations
Time frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Blood samples are collected after high-fat and low-fat meals on two study days.
2 secondary outcomes
Postprandial peak mean of cardiovascular risk markers concentrations
Time frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
Laboratory tests of fecal samples
Time frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.
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 1 Dec 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.
Else Bladbjerg, M.Sc. PhD study chair
Unit for Thrombosis Research, Department of Regional Health Research, Hospital of South West Jutland and University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental diet in people with Morbid Obesity and Weight Loss, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 2 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 1 Dec 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 Denmark. 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?
Postprandial peak mean of prothrombin fragment 1+2 concentrations (time frame: Measures before weight loss, change from baseline to after lifestyle-induced weight loss and 4 months post-surgery.). 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 1 Dec 2021.