Type 1 Diabetes MellitusPhase 4NCT01668485
Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation
A Phase 4 study testing Hypoglycemic and euglycemic glucose clamp in people with Type 1 Diabetes Mellitus, run by University of Giessen at 1 site in Germany.
Trial summary
Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Hypoglycemic and euglycemic glucose clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2001to Nov 2011
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Type 1 Diabetes
- Pancreatic islet transplantation
Who cannot join
- Type 2 Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.
Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.
Read the detailed description
Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Hypoglycemic and euglycemic glucose clamp
- Keywords
- Type 1 diabetes mellitus, hypoglycemia counterregulation,, pancreatic islet transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemic and euglycemic glucose clampProcedure or surgery
Each study participant will be subjected to a continuous infusion of insulin at a rate of 0.8 mU·kg-1·min-1 to induce hypoglycemia (blood glucose 2.8-3 mmol/l) for 30 minutes. At least two weeks later an identical insulin infusion will be administered and euglycemia (blood glucose 5 mmol/l) will be targeted. The order of these interventions will be subject to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Islet transplant recipients | Experimental | Hypoglycemic and euglycemic glucose clamp Receives: Procedure: Hypoglycemic and euglycemic glucose clamp |
| Type 1 diabetic subjects | Placebo comparator | Hypoglycemic and euglycemic glucose clamp. Receives: Procedure: Hypoglycemic and euglycemic glucose clamp |
| Non-diabetic subjects | Active comparator | Hypoglycemic and euglycemic glucose clamp Receives: Procedure: Hypoglycemic and euglycemic glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body glucose counterregulation
Whole body glucose counterregulation is the difference in glucose infusion rates required to maintain the glycemic goal between the hypoglycemic and euglycemic clamp. Clamps were performed at two time points at least two weeks apart. Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests.
Measured: 6-8 weeks
Secondary outcomes (3)
Systemic glucose release
Systemic glucose release is the amount of glucose released primarily from the liver into the blood compartment during a given time. The unit of measure is μmol/kg/min.
Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests that will yield this parameter.
Measured: 6-8 weeks
Skeletal muscle glucose disposal
Participants will be followed for the duration of 6-8 weeks to perform the euglycemic and hypoglycemic clamp tests. The unit of measure of this parameters is μmol/kg/min.
Measured: 6-8 weeks
Gluconeogenesis from lactate
This parameter is determined by labelled lactate infused into the proband. The rate of the de novo synthesis of glucose (gluconeogenesis) is determined by the degree of incorporation of the lactate label into glucose molecules. The unit of measure of this parameter is μmol/kg/min.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startNov 2001
- Primary completionNov 2010
- Study completionNov 2011
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 1 Diabetes MellitusStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Linn, University of Giessen
- Investigators
- Thomas Linn, MD, Principal investigator, Justus Liebig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668485
- Sponsor's protocol ID
- T1DM/ITX
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ang M, Meyer C, Brendel MD, Bretzel RG, Linn T. Magnitude and mechanisms of glucose counterregulation following islet transplantation in patients with type 1 diabetes suffering from severe hypoglycaemic episodes. Diabetologia. 2014 Mar;57(3):623-32. doi: 10.1007/s00125-013-3120-9. Epub 2013 Dec 5.
PubMed 24305963
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.
- ClinicalTrials.gov ID
- NCT01668485
- Acronym / sponsor ID
- T1DM/ITX
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, hypoglycemia counterregulation,, pancreatic islet transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Aug 2012 (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.
Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.
Detailed description
Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Islet transplant recipients | Experimental | Procedure: Hypoglycemic and euglycemic glucose clampHypoglycemic and euglycemic glucose clamp |
| Type 1 diabetic subjects | Placebo comparator | Procedure: Hypoglycemic and euglycemic glucose clampHypoglycemic and euglycemic glucose clamp. |
| Non-diabetic subjects | Active comparator | Procedure: Hypoglycemic and euglycemic glucose clampHypoglycemic and euglycemic glucose clamp |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 Diabetes
- Pancreatic islet transplantation
Key exclusion criteria (1 listed)
- Type 2 Diabetes
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 |
|---|---|---|
| Hypoglycemic and euglycemic glucose clampEach study participant will be subjected to a continuous infusion of insulin at a rate of 0.8 mU·kg-1·min-1 to induce hypoglycemia (blood glucose 2.8-3 mmol/l) for 30 minutes. At least two weeks later an identical insulin infusion will be administered and euglycemia (blood glucose 5 mmol/l) will be targeted. The order of these interventions will be subject to randomization. | Procedure or surgery | Islet transplant recipients, Non-diabetic subjects, Type 1 diabetic subjects |
Primary outcome
Whole body glucose counterregulation
Time frame: 6-8 weeks
Whole body glucose counterregulation is the difference in glucose infusion rates required to maintain the glycemic goal between the hypoglycemic and euglycemic clamp. Clamps were performed at two time points at least two weeks apart. Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests.
3 secondary outcomes
Systemic glucose release
Time frame: 6-8 weeks
Skeletal muscle glucose disposal
Time frame: 6-8 weeks
Gluconeogenesis from lactate
Time frame: 6-8 weeks
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 Aug 2012.
- Derived from this study: PubMed 24305963Ang M, Meyer C, Brendel MD, Bretzel RG, Linn T. Magnitude and mechanisms of glucose counterregulation following islet transplantation in patients with type 1 diabetes suffering from severe hypoglycaemic episodes. Diabetologia. 2014 Mar;57(3):623-32. doi: 10.1007/s00125-013-3120-9. Epub 2013 Dec 5.
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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.
Thomas Linn, MD principal investigator
Justus Liebig 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 Hypoglycemic and euglycemic glucose clamp in people with Type 1 Diabetes Mellitus, run by University of Giessen at 1 site in Germany.
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 21 Aug 2012. 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 Germany. 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?
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?
Whole body glucose counterregulation (time frame: 6-8 weeks). 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 NCT01668485, 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 21 Aug 2012.