Type 2 DiabetesNCT02235584
Insulinotropic Effect of GLP-1 and GIP After Dexamethasone
A study testing Dexamethasone in people with Type 2 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Jun 2014
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasians above 20 and below 45 years of age
- Normal glucose tolerance as assessed by the WHO criteria
- First degree relative and at least 1 second degree relative with type 2 diabetes
- Normal haemoglobin
- Informed consent
Who cannot join
- Liver disease (ALAT/ASAT > 2 times normal value)
- Kidney disease (S-creatinin > 130uM and/or albuminuria)
- Heart disease (NYHA II, III or IV)
- Treatment with medicine that cannot be paused
- Pregnancy of breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance
In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.
Read the detailed description
In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.
Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.
To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.
Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance
- Conditions
- Type 2 Diabetes
- Being tested
- Dexamethasone
- Keywords
- Incretin hormones, GLP-1, GIP, Dexamethasone
- 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.
DexamethasoneDrug
Dexamethasone are given dexamethasone tablets of 2mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l
After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.
Measured: 1-3 days after dexamethasone treatment
Secondary outcomes (3)
First phase insulin response to GLP-1 infusion at 7mmol/l
Measured: 1-3 days after dexamethasone
First phase insulin response to GIP infusion at 7mmol/l
Measured: 1-3 days after dexamethasone
Second phase insulin response to GIP infusion at 7mmol/l
Measured: 1-3 days after dexamethasone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2009
- Primary completionJun 2014
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 Type 2 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
- Investigators
- Thure Krarup, dr. med., Study director, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235584
- Sponsor's protocol ID
- H-D-2009-070
- Status last verified
- Sep 2014
- First submitted
- 7 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksen M, Jensen DH, Tribler S, Holst JJ, Madsbad S, Krarup T. Reduction of insulinotropic properties of GLP-1 and GIP after glucocorticoid-induced insulin resistance. Diabetologia. 2015 May;58(5):920-8. doi: 10.1007/s00125-015-3522-y. Epub 2015 Mar 9.
PubMed 25748606
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance
- ClinicalTrials.gov ID
- NCT02235584
- Acronym / sponsor ID
- H-D-2009-070
- Conditions
- Type 2 Diabetes
- Keywords
- Incretin hormones, GLP-1, GIP, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- First posted
- 10 Sep 2014 (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.
In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.
Detailed description
In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.
Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.
To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.
Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneThis is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasians above 20 and below 45 years of age
- Normal glucose tolerance as assessed by the WHO criteria
- First degree relative and at least 1 second degree relative with type 2 diabetes
- Normal haemoglobin
- Informed consent
Key exclusion criteria (5 listed)
- Liver disease (ALAT/ASAT > 2 times normal value)
- Kidney disease (S-creatinin > 130uM and/or albuminuria)
- Heart disease (NYHA II, III or IV)
- Treatment with medicine that cannot be paused
- Pregnancy of breast feeding
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 |
|---|---|---|
| DexamethasoneDexamethasone are given dexamethasone tablets of 2mg twice daily. | Drug | Dexamethasone |
Primary outcome
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l
Time frame: 1-3 days after dexamethasone treatment
After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.
3 secondary outcomes
First phase insulin response to GLP-1 infusion at 7mmol/l
Time frame: 1-3 days after dexamethasone
First phase insulin response to GIP infusion at 7mmol/l
Time frame: 1-3 days after dexamethasone
Second phase insulin response to GIP infusion at 7mmol/l
Time frame: 1-3 days after dexamethasone treatment
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 10 Sep 2014.
- Derived from this study: PubMed 25748606Eriksen M, Jensen DH, Tribler S, Holst JJ, Madsbad S, Krarup T. Reduction of insulinotropic properties of GLP-1 and GIP after glucocorticoid-induced insulin resistance. Diabetologia. 2015 May;58(5):920-8. doi: 10.1007/s00125-015-3522-y. Epub 2015 Mar 9.
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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.
Thure Krarup, dr. med. study director
Bispebjerg 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 Dexamethasone in people with Type 2 Diabetes, 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 5 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 10 Sep 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 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?
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l (time frame: 1-3 days after dexamethasone treatment). 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 NCT02235584, 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 10 Sep 2014.