Severe ObesityNCT02336659
Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
A study testing exendin 9-39 and sitagliptin in people with Severe Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- exendin 9-39 and sitagliptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jun 2016
- 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
- Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose <7.0 mM and HbA1c < 48 mmol/mol 3 month after RYGB.
Who cannot join
- Fasting plasma glucose >7.0 mM and HbA1c > 48 mmol/mol 3 month after RYGB. Hemoglobin <6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
- Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.
Read the detailed description
To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.
- Conditions
- Severe Obesity
- Being tested
- exendin 9-39, sitagliptin, Placebo
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exendin 9-39Drug
Also called GLP-1 antagonist
Exendin 9-39 is a specific GLP-1 receptor antagonist
sitagliptinDrug
Also called Januvia
DPP-4 Inhibition
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Mixed meal test and ad libitum meal test duing infusion of saline Receives: Other: Placebo |
| Exendin 9-39 | Experimental | Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min Receives: Drug: exendin 9-39 |
| DPP-4 Inhibition | Experimental | Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2 Receives: Drug: sitagliptin |
| Exendin 9-39 / DPP 4-Inhibition | Experimental | Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg * 2 Receives: Drug: exendin 9-39; Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake (changes in food intake)
Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor
Measured: 3-12 month after RYGB
Secondary outcomes (3)
Glucose metabolism (iAUC of glucose and c-pep after a meal)
Evaluated by iAUC of glucose and c-pep after a meal
Measured: 3-12 month after RYGB
Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
Evaluated by iAUC of GLP-1, PYY, GIP and glucagon after a meal
Measured: 3-12 month after RYGB
Appetite measurement (VAS-scores)
Evaluated by VAS-scores
Measured: 3-12 month after RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Maria Saur Svane, Hvidovre University Hospital
- Investigators
- Sten Madbad, MD, DMSc, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336659
- Sponsor's protocol ID
- MSV-14
- Status last verified
- Jun 2016
- First submitted
- 8 Jan 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02336659
- Acronym / sponsor ID
- MSV-14
- Conditions
- Severe Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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 aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.
Detailed description
To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: PlaceboMixed meal test and ad libitum meal test duing infusion of saline |
| Exendin 9-39 | Experimental | Drug: exendin 9-39Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min |
| DPP-4 Inhibition | Experimental | Drug: sitagliptinMixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2 |
| Exendin 9-39 / DPP 4-Inhibition | Experimental | Drug: exendin 9-39, Drug: sitagliptinMixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg * 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose <7.0 mM and HbA1c < 48 mmol/mol 3 month after RYGB.
Key exclusion criteria (2 listed)
- Fasting plasma glucose >7.0 mM and HbA1c > 48 mmol/mol 3 month after RYGB. Hemoglobin <6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
- Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).
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 |
|---|---|---|
| exendin 9-39Also: GLP-1 antagonistExendin 9-39 is a specific GLP-1 receptor antagonist | Drug | Exendin 9-39, Exendin 9-39 / DPP 4-Inhibition |
| sitagliptinAlso: JanuviaDPP-4 Inhibition | Drug | DPP-4 Inhibition, Exendin 9-39 / DPP 4-Inhibition |
| PlaceboSaline | Other | Saline |
Primary outcome
Ad libitum food intake (changes in food intake)
Time frame: 3-12 month after RYGB
Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor
3 secondary outcomes
Glucose metabolism (iAUC of glucose and c-pep after a meal)
Time frame: 3-12 month after RYGB
Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)
Time frame: 3-12 month after RYGB
Appetite measurement (VAS-scores)
Time frame: 3-12 month after RYGB
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 21 Jun 2016.
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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.
Sten Madbad, MD, DMSc study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exendin 9-39 and sitagliptin in people with Severe 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 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 21 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Ad libitum food intake (changes in food intake) (time frame: 3-12 month after RYGB). 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 21 Jun 2016.