Bariatric SurgeryFAT-BARNCT04859816
Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
A study testing Metabolic test, DXA-scan and MRS in people with Bariatric Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Metabolic test, DXA-scan and MRS
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 May 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- RYGB > 12 months prior to inclusion
- Weight stable (± 3 kg during the last month)
- HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
- Age > 18 years
Show all 9Show fewer
- No former bariatric surgery
- Weight stable (± 3 kg during the last month)
- HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1, and no history of diabetes
Who cannot join
- Thyrotoxicosis or inadequately treated hypothyreosis
- Haemoglobin < 6.5 mmol/l at inclusion
- Pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding
- Medication affecting the planned examinations which cannot be paused during the study period.
- Adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet)
- Complications restricting eating behavior (e.g. postprandial hypoglycemia, vomiting or strictures)
- MR contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.
- Conditions
- Bariatric Surgery
- Being tested
- Metabolic test, DXA-scan, MRS, Feces collection
- Keywords
- fat, triglyceride, triacylglycerol, Roux-en-Y gastric bypass, malabsorption
- Medical subject headings
- Platelet Glycoprotein IV Deficiency, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic testOther
Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal
DXA-scanOther
Dual energy X-ray Absorptiometry scan of whole-body fat
MRSOther
Magnetic resonance spectroscopy of liver fat content
Feces collectionOther
4-day feces collection
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass operated participants | Experimental | Roux-en-Y gastric bypass operated participants in weight stable phase > 1 year from surgery Receives: Other: Metabolic test; Other: DXA-scan; Other: MRS; Other: Feces collection |
| Control participants | Experimental | Age, sex, and BMI-matched un-operated participants. Receives: Other: Metabolic test; Other: DXA-scan; Other: MRS; Other: Feces collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of plasma triacylglycerol
During a high-fat liquid mixed meal test
Measured: 6 hours
Secondary outcomes (1)
Recovery of oral stable triacylglycerol isotope tracer in feces
An oral stable triacylglycerol isotope tracer will be administered during a high-fat liquid mixed meal test. Feces will be collected the following 4 days to determine the recovery of the tracer in feces.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Gadegaard Hindsø, MD, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859816
- Sponsor's protocol ID
- FAT-BAR
- Acronym
- FAT-BAR
- Status last verified
- Aug 2022
- First submitted
- 12 Apr 2021
- Last updated
- 23 Aug 2022
- Results posted
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT04859816
- Acronym / sponsor ID
- FAT-BAR / FAT-BAR
- Conditions
- Bariatric Surgery
- Keywords
- fat, triglyceride, triacylglycerol, Roux-en-Y gastric bypass, malabsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Apr 2021 (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.
Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass operated participants | Experimental | Other: Metabolic test, Other: DXA-scan, Other: MRS, Other: Feces collectionRoux-en-Y gastric bypass operated participants in weight stable phase > 1 year from surgery |
| Control participants | Experimental | Other: Metabolic test, Other: DXA-scan, Other: MRS, Other: Feces collectionAge, sex, and BMI-matched un-operated participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- RYGB > 12 months prior to inclusion
- Weight stable (± 3 kg during the last month)
- HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
Key exclusion criteria (7 listed)
- Thyrotoxicosis or inadequately treated hypothyreosis
- Haemoglobin < 6.5 mmol/l at inclusion
- Pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding
- Medication affecting the planned examinations which cannot be paused during the study period.
- Adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet)
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 |
|---|---|---|
| Metabolic testIv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal | Other | Control participants, Roux-en-Y gastric bypass operated participants |
| DXA-scanDual energy X-ray Absorptiometry scan of whole-body fat | Other | Control participants, Roux-en-Y gastric bypass operated participants |
| MRSMagnetic resonance spectroscopy of liver fat content | Other | Control participants, Roux-en-Y gastric bypass operated participants |
| Feces collection4-day feces collection | Other | Control participants, Roux-en-Y gastric bypass operated participants |
Primary outcome
Area under the curve of plasma triacylglycerol
Time frame: 6 hours
During a high-fat liquid mixed meal test
1 secondary outcome
Recovery of oral stable triacylglycerol isotope tracer in feces
Time frame: 4 days
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 23 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic test, DXA-scan and MRS in people with Bariatric Surgery, run by Hvidovre University Hospital 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 9 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 23 Aug 2022. 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?
Area under the curve of plasma triacylglycerol (time frame: 6 hours). 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 23 Aug 2022.