Glucose Metabolism DisordersObesityNCT04082923
Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery
A study testing Liquid meal and Solid meal in people with Glucose Metabolism Disorders and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Obesity, Sleeve Gastrectomy
- What is being tested?
- Liquid meal and Solid meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2019to 1 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- RYGB or SG operation > 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
Who cannot join
- Thyrotoxicosis or inadequately treated hypothyreosis
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
About this study
Official title: Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.
- Being tested
- Liquid meal, Solid meal
- Medical subject headings
- Glucose Metabolism Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid mealOther
Four-hour liquid mixed meal test
Solid mealOther
Four-hour solid mixed meal test
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass operated patients | Other | Two test days in a randomized, patient-blinded, cross-over design Receives: Other: Liquid meal; Other: Solid meal |
| Gastric sleeve operated patients | Other | Two test days in a randomized, patient-blinded, cross-over design Receives: Other: Liquid meal; Other: Solid meal |
| Control arm | Other | Two test days in a randomized, patient-blinded, cross-over design Receives: Other: Liquid meal; Other: Solid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 response
GLP-1 response after a liquid meal test compared to a solid meal test
Measured: 240 minutes
Secondary outcomes (1)
Difference in gut hormone response after bariatric surgery
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start3 Oct 2019
- Primary completion1 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Elisabeth Hedbäck, Hvidovre University Hospital
- Investigators
- NOra Hedbäck, MD, Principal investigator, Department of Endocrinology Hvidovre Hospital Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082923
- Sponsor's protocol ID
- H-19027100
- Acronym
- Obesity
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hedback N, Hindso M, Bojsen-Moller KN, Linddal AK, Jorgensen NB, Dirksen C, Moller A, Kristiansen VB, Hartmann B, Holst JJ, Svane MS, Madsbad S. Effect of Meal Texture on Postprandial Glucose Excursions and Gut Hormones After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Front Nutr. 2022 Apr 29;9:889710. doi: 10.3389/fnut.2022.889710. eCollection 2022.
PubMed 35571890
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?
- ClinicalTrials.gov ID
- NCT04082923
- Acronym / sponsor ID
- Obesity / H-19027100
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 10 Sep 2019 (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 investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass operated patients | Other | Other: Liquid meal, Other: Solid mealTwo test days in a randomized, patient-blinded, cross-over design |
| Gastric sleeve operated patients | Other | Other: Liquid meal, Other: Solid mealTwo test days in a randomized, patient-blinded, cross-over design |
| Control arm | Other | Other: Liquid meal, Other: Solid mealTwo test days in a randomized, patient-blinded, cross-over design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- RYGB or SG operation > 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 (4 listed)
- Thyrotoxicosis or inadequately treated hypothyreosis
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
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 |
|---|---|---|
| Liquid mealFour-hour liquid mixed meal test | Other | Control arm, Gastric bypass operated patients, Gastric sleeve operated patients |
| Solid mealFour-hour solid mixed meal test | Other | Control arm, Gastric bypass operated patients, Gastric sleeve operated patients |
Primary outcome
GLP-1 response
Time frame: 240 minutes
GLP-1 response after a liquid meal test compared to a solid meal test
1 secondary outcome
Difference in gut hormone response after bariatric surgery
Time frame: 240 minutes
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 Sep 2021.
- Derived from this study: PubMed 35571890Hedback N, Hindso M, Bojsen-Moller KN, Linddal AK, Jorgensen NB, Dirksen C, Moller A, Kristiansen VB, Hartmann B, Holst JJ, Svane MS, Madsbad S. Effect of Meal Texture on Postprandial Glucose Excursions and Gut Hormones After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Front Nutr. 2022 Apr 29;9:889710. doi: 10.3389/fnut.2022.889710. eCollection 2022.
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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.
NOra Hedbäck, MD principal investigator
Department of Endocrinology Hvidovre Hospital 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 Liquid meal and Solid meal in people with Glucose Metabolism Disorders and Obesity, 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 5 inclusion and 4 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 Sep 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?
GLP-1 response (time frame: 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082923, which also lists 1 linked publication.
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 Sep 2021.