Type 2 Diabetes MellitusNCT00654056
Severe Insulin Resistance in Patients With Type 2 Diabetes
A study testing Actrapid (human insulin) in people with Type 2 Diabetes Mellitus, run by University of Aarhus.
Trial summary
The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Actrapid (human insulin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Oct 2009
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-75 years old
- BMI between 25 and 42
Who cannot join
- Severe diseases
About this study
Official title: Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.
The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.
Read the detailed description
Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. Our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. Moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Actrapid (human insulin)
- Keywords
- Type 2 diabetes, Severe insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actrapid (human insulin)Drug
On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours
| Study group | Role | What they receive |
|---|---|---|
| L1 | Experimental | Actrapid infusion, 0.5 mU/kg/min. Receives: Drug: Actrapid (human insulin) |
| L2 | Experimental | Actrapid infusion 1.5 mU/kg/min Receives: Drug: Actrapid (human insulin) |
| H1 | Experimental | Actrapid infusion 3.0 mU/kg/min Receives: Drug: Actrapid (human insulin) |
| H2 | Experimental | Actrapid infusion 5.0 mU/kg/min Receives: Drug: Actrapid (human insulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 8 hours
Secondary outcomes (1)
Changes in insulin signaling proteins?
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Niels Moeller, Professor, Principal investigator, Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654056
- Sponsor's protocol ID
- UKO-M20070267
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2008
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.
- ClinicalTrials.gov ID
- NCT00654056
- Acronym / sponsor ID
- UKO-M20070267
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, Severe insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Apr 2008 (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 purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.
Detailed description
Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. Our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. Moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| L1 | Experimental | Drug: Actrapid (human insulin)Actrapid infusion, 0.5 mU/kg/min. |
| L2 | Experimental | Drug: Actrapid (human insulin)Actrapid infusion 1.5 mU/kg/min |
| H1 | Experimental | Drug: Actrapid (human insulin)Actrapid infusion 3.0 mU/kg/min |
| H2 | Experimental | Drug: Actrapid (human insulin)Actrapid infusion 5.0 mU/kg/min |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 25-75 years old
- BMI between 25 and 42
Key exclusion criteria (1 listed)
- Severe diseases
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 |
|---|---|---|
| Actrapid (human insulin)On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours | Drug | H1, H2, L1, L2 |
Primary outcome
Insulin sensitivity
Time frame: 8 hours
1 secondary outcome
Changes in insulin signaling proteins?
Time frame: 1 month
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 11 Mar 2013.
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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.
Niels Moeller, Professor principal investigator
Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Actrapid (human insulin) in people with Type 2 Diabetes Mellitus, run by University of Aarhus.
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 2 inclusion and 1 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 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Insulin sensitivity (time frame: 8 hours). 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 11 Mar 2013.