HealthyPhase 4NCT00885638
Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion
A Phase 4 study testing Sitagliptin in people with Healthy and Type 2 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 2 Diabetes
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- Age 20-30 years
- BMI 20-30 kg/m2
Who cannot join
- Any disease
- Any medication
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences Lund, Lund University
Lund, 221 84
About this study
Official title: Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers
The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
Read the detailed description
Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
- Conditions
- Healthy, Type 2 Diabetes
- Being tested
- Sitagliptin, placebo
- Keywords
- GLP-1, Insulin secretion, Macronutrients
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
100 mg sitagliptin before ingestion of macronutrient
placeboDrug
A placebo tablet is given before ingestion of macronutrients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A placebo tablet is given before ingestion of macronutrients Receives: Drug: placebo |
| Sitagliptin | Active comparator | Sitagliptin is given before ingestion of macronutrients Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon-like Peptide-1 Secretion After Meal Ingestion
Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion
Measured: 300 min
Secondary outcomes (1)
Insulin Secretion After Ingestion of Meal
Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion
Measured: 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ahren, Lund University
- Investigators
- Bo Ahrén, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885638
- Sponsor's protocol ID
- Lund University Diabetes 001
- Status last verified
- Dec 2013
- First submitted
- 21 Apr 2009
- Last updated
- 30 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carr RD, Larsen MO, Winzell MS, Jelic K, Lindgren O, Deacon CF, Ahren B. Incretin and islet hormonal responses to fat and protein ingestion in healthy men. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E779-84. doi: 10.1152/ajpendo.90233.2008. Epub 2008 Jul 8.
PubMed 18612044Ohlsson L, Alsalim W, Carr RD, Tura A, Pacini G, Mari A, Ahren B. Glucose-lowering effect of the DPP-4 inhibitor sitagliptin after glucose and non-glucose macronutrient ingestion in non-diabetic subjects. Diabetes Obes Metab. 2013 Jun;15(6):531-7. doi: 10.1111/dom.12062. Epub 2013 Feb 7.
PubMed 23331498
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Sitagliptin on the Hormonal Responses to Macronutrient Ingestion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00885638
- Acronym / sponsor ID
- Lund University Diabetes 001
- Conditions
- Healthy, Type 2 Diabetes
- Keywords
- GLP-1, Insulin secretion, Macronutrients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 15 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
Detailed description
Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboA placebo tablet is given before ingestion of macronutrients |
| Sitagliptin | Active comparator | Drug: SitagliptinSitagliptin is given before ingestion of macronutrients |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- Age 20-30 years
- BMI 20-30 kg/m2
Key exclusion criteria (2 listed)
- Any disease
- Any medication
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 |
|---|---|---|
| SitagliptinAlso: Januvia100 mg sitagliptin before ingestion of macronutrient | Drug | Sitagliptin |
| placeboA placebo tablet is given before ingestion of macronutrients | Drug | Placebo |
Primary outcome
Glucagon-like Peptide-1 Secretion After Meal Ingestion
Time frame: 300 min
Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion
1 secondary outcome
Insulin Secretion After Ingestion of Meal
Time frame: 300 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18612044Carr RD, Larsen MO, Winzell MS, Jelic K, Lindgren O, Deacon CF, Ahren B. Incretin and islet hormonal responses to fat and protein ingestion in healthy men. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E779-84. doi: 10.1152/ajpendo.90233.2008. Epub 2008 Jul 8.
- Derived from this study: PubMed 23331498Ohlsson L, Alsalim W, Carr RD, Tura A, Pacini G, Mari A, Ahren B. Glucose-lowering effect of the DPP-4 inhibitor sitagliptin after glucose and non-glucose macronutrient ingestion in non-diabetic subjects. Diabetes Obes Metab. 2013 Jun;15(6):531-7. doi: 10.1111/dom.12062. Epub 2013 Feb 7.
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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.
Bo Ahrén, MD, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin in people with Healthy and Type 2 Diabetes, run by Lund University at 1 site in Sweden.
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 3 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 30 Jan 2014. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glucagon-like Peptide-1 Secretion After Meal Ingestion (time frame: 300 min). 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 NCT00885638, which also lists 2 linked publications.
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 30 Jan 2014.