Insulin ResistanceNCT01173978
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance
A study testing Steroid hormone in people with Insulin Resistance and Deteriorated Glucose Homeostasis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Deteriorated Glucose Homeostasis, Inactivity
- What is being tested?
- Steroid hormone
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Jul 2010
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasians without type 2 diabetes mellitus
- Normal OGTT (75 g of glucose) according to WHO's criteria
- BMI 20-30
- Hemoglobin > 8.0 mmol/l
- Informed consent
Who cannot join
- Liver disease (ALAT > 2 x normal level)
- Nephropathy (s-creatinin > 130 µM or albuminuria)
- Relatives (parents/siblings) with T2DM
- Medical treatment witch cannot be stopped for 12 hours
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology
Glostrup Municipality, DK-2600
About this study
Official title: Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet
The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.
Read the detailed description
The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.
- Being tested
- Steroid hormone, No intervention
- Keywords
- Incretin hormones, Glucagon, Insulin/c-peptide, Plasma glucose, Insulin resistance, Deteriorated glucose homeostasis, Inactivity
- Medical subject headings
- Insulin Resistance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid hormoneBehavioural
Also called Prednisolone
Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Experimental | Each participant is examined during a normal, active lifestyle, without any intervention: The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl Receives: Other: No intervention |
| Intervention | Experimental | Each participant is examined during a 12 days intervention.The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl Receives: Behavioral: Steroid hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulinotropic effect of incretin hormones
Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity
Measured: 12 days
Secondary outcomes (1)
Plasma concentration of glucagon
Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes
- Investigators
- Katrine B Hansen, MD, Principal investigator, Glostrup University HospitalFilip K Knop, MD,PhD, Study chair, Gentofte University HospitalTina Vilsbøll, MD,DmSc, Study chair, Gentofte University HospitalJens J Holst, MD, DmSc, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173978
- Sponsor's protocol ID
- DYS-CLAMP
- Status last verified
- Jul 2010
- First submitted
- 7 Jun 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet
- ClinicalTrials.gov ID
- NCT01173978
- Acronym / sponsor ID
- DYS-CLAMP
- Keywords
- Incretin hormones, Glucagon, Insulin/c-peptide, Plasma glucose, Insulin resistance, Deteriorated glucose homeostasis, Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, European Foundation for the Study of Diabetes
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Aug 2010 (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 incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.
Detailed description
The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | Experimental | Other: No interventionEach participant is examined during a normal, active lifestyle, without any intervention: The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl |
| Intervention | Experimental | Behavioral: Steroid hormoneEach participant is examined during a 12 days intervention.The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasians without type 2 diabetes mellitus
- Normal OGTT (75 g of glucose) according to WHO's criteria
- BMI 20-30
- Hemoglobin > 8.0 mmol/l
- Informed consent
Key exclusion criteria (4 listed)
- Liver disease (ALAT > 2 x normal level)
- Nephropathy (s-creatinin > 130 µM or albuminuria)
- Relatives (parents/siblings) with T2DM
- Medical treatment witch cannot be stopped for 12 hours
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 |
|---|---|---|
| Steroid hormoneAlso: PrednisoloneSteroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day | Behavioural | Intervention |
| No intervention | Other | No intervention |
Primary outcome
Insulinotropic effect of incretin hormones
Time frame: 12 days
Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity
1 secondary outcome
Plasma concentration of glucagon
Time frame: 12 days
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 2011.
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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.
Katrine B Hansen, MD principal investigator
Glostrup University Hospital
Filip K Knop, MD,PhD study chair
Gentofte University Hospital
Tina Vilsbøll, MD,DmSc study chair
Gentofte 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 Steroid hormone in people with Insulin Resistance and Deteriorated Glucose Homeostasis, run by Glostrup University Hospital, Copenhagen 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 21 Jun 2011. 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?
Insulinotropic effect of incretin hormones (time frame: 12 days). 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 2011.