Bariatric SurgeryINCA-BARNCT03950245
Incretin Hormone Antagonism After Bariatric Surgery
A study testing GLP-1 antagonism, GIP antagonism and GLP-1 and GIP antagonism in people with Bariatric Surgery, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- GLP-1 antagonism, GIP antagonism and GLP-1 and GIP antagonism
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2019to 16 Apr 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
- Age > 18 years
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- no former RYGB- or SG operation
- Weight stable (± 3 kg during the last month)
- HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1 mmol/l and no history of diabetes
Who cannot join
- Thyrotoxicosis or inadequately treated hypothyreosis
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
- Matching between groups
- Age
- Sex
- BMI at inclusion and for surgery groups also pre-surgery BMI
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Endocrinology
Hvidovre, 2650
Hvidovre Hospital
Hvidovre
About this study
Official title: Importance of Endogenous Glucagon-like Peptide-1 and Glucose-dependent Insulinotropic Polypeptide for Postprandial Glucose Metabolism After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Surgery
Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.
- Conditions
- Bariatric Surgery
- Being tested
- Placebo, GLP-1 antagonism, GIP antagonism, GLP-1 and GIP antagonism
- Keywords
- glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, Roux-en-Y gastric bypass, sleeve gastrectomy, gastric bypass, bariatric surgery, glucose, diabetes, exendin(9-39), GIP(3-30)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
GLP-1 antagonismOther
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
GIP antagonismOther
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
GLP-1 and GIP antagonismOther
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass operated patients | Other | Four test days in a randomized, patient-blinded, cross-over design Receives: Other: Placebo; Other: GLP-1 antagonism; Other: GIP antagonism; Other: GLP-1 and GIP antagonism |
| Sleeve gastrectomy operated patients | Other | Four test days in a randomized, patient-blinded cross-over, design Receives: Other: Placebo; Other: GLP-1 antagonism; Other: GIP antagonism; Other: GLP-1 and GIP antagonism |
| Un-operated controls | Other | Four test days in a randomized, patient-blinded cross-over, design Receives: Other: Placebo; Other: GLP-1 antagonism; Other: GIP antagonism; Other: GLP-1 and GIP antagonism |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC glucose
Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group
Measured: 240 minutes
Secondary outcomes (1)
Beta-cell glucose sensitivity (β-GS)
Main comparison between groups: delta β-GS (β-GS exendin(9-39) test day - β-GS GIP(3-30) test day) in the RYGB group compared to the SG group
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 posted15 May 2019
- Study start1 Jul 2019
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
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
- 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, Morten Gadegaard Hindsø, MD, Hvidovre University Hospital
- Investigators
- Kirstine N Bojsen-Møller, MD, PHD, Principal investigator, Dept. of Endocrinology, Hvidovre Hospital, DenmarkMorten G Hindsø, MD, Principal investigator, Dept. of Endocrinology, Hvidovre Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950245
- Sponsor's protocol ID
- MH-INKA-BAR-19
- Acronym
- INCA-BAR
- Status last verified
- Jan 2022
- First submitted
- 13 May 2019
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Endogenous Glucagon-like Peptide-1 and Glucose-dependent Insulinotropic Polypeptide for Postprandial Glucose Metabolism After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT03950245
- Acronym / sponsor ID
- INCA-BAR / MH-INKA-BAR-19
- Conditions
- Bariatric Surgery
- Keywords
- glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, Roux-en-Y gastric bypass, sleeve gastrectomy, gastric bypass, bariatric surgery, glucose, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 15 May 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.
Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.
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: Placebo, Other: GLP-1 antagonism, Other: GIP antagonism, Other: GLP-1 and GIP antagonismFour test days in a randomized, patient-blinded, cross-over design |
| Sleeve gastrectomy operated patients | Other | Other: Placebo, Other: GLP-1 antagonism, Other: GIP antagonism, Other: GLP-1 and GIP antagonismFour test days in a randomized, patient-blinded cross-over, design |
| Un-operated controls | Other | Other: Placebo, Other: GLP-1 antagonism, Other: GIP antagonism, Other: GLP-1 and GIP antagonismFour 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 (9 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 (8 listed)
- Thyrotoxicosis or inadequately treated hypothyreosis
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
- Matching between groups
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 |
|---|---|---|
| PlaceboFour-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion. | Other | Gastric bypass operated patients, Sleeve gastrectomy operated patients, Un-operated controls |
| GLP-1 antagonismFour-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion. | Other | Gastric bypass operated patients, Sleeve gastrectomy operated patients, Un-operated controls |
| GIP antagonismFour-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion. | Other | Gastric bypass operated patients, Sleeve gastrectomy operated patients, Un-operated controls |
| GLP-1 and GIP antagonismFour-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion. | Other | Gastric bypass operated patients, Sleeve gastrectomy operated patients, Un-operated controls |
Primary outcome
iAUC glucose
Time frame: 240 minutes
Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group
1 secondary outcome
Beta-cell glucose sensitivity (β-GS)
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 Feb 2022.
- 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.
Kirstine N Bojsen-Møller, MD, PHD principal investigator
Dept. of Endocrinology, Hvidovre Hospital, Denmark
Morten G Hindsø, MD principal investigator
Dept. of Endocrinology, Hvidovre Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 antagonism, GIP antagonism and GLP-1 and GIP antagonism in people with Bariatric Surgery, run by Hvidovre University Hospital at 2 sites 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 8 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 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
iAUC glucose (time frame: 240 minutes). 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 Feb 2022.