Diabetes Mellitus, Type 1NCT01123122
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation
A study of Diabetes Mellitus, Type 1 and Islet Transplantation, run by Vancouver Coastal Health at 1 site in Canada.
Trial summary
Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Islet Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Sep 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- more than 5 years since diagnosis of diabetes
- c-peptide negative
Who cannot join
- ischemic heart disease
- previous transplant
- recurrent infections
- malignancy (except basal or squamous skin cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.
- Conditions
- Diabetes Mellitus, Type 1, Islet Transplantation
- Being tested
- Strict glucose control
- 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.
Strict glucose controlOther
Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Strict glucose control | Active comparator | Not described Receives: Other: Strict glucose control |
| Standard glucose control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Islet cell function
Function will be assessed three months post-transplantation.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startSep 2011
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health
- Sponsor type
- Other government
- Investigators
- David M Thompson, MD, Principal investigator, Vancouver General Hospital Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123122
- Sponsor's protocol ID
- VGHEndo0510
- Status last verified
- May 2011
- First submitted
- 13 May 2010
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
PubMed 10911004Shapiro AM, Ricordi C, Hering B. Edmonton's islet success has indeed been replicated elsewhere. Lancet. 2003 Oct 11;362(9391):1242. doi: 10.1016/S0140-6736(03)14526-6. No abstract available.
PubMed 14568760Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.
PubMed 15983207Rickels MR, Schutta MH, Markmann JF, Barker CF, Naji A, Teff KL. beta-Cell function following human islet transplantation for type 1 diabetes. Diabetes. 2005 Jan;54(1):100-6. doi: 10.2337/diabetes.54.1.100.
PubMed 15616016Eich T, Eriksson O, Lundgren T; Nordic Network for Clinical Islet Transplantation. Visualization of early engraftment in clinical islet transplantation by positron-emission tomography. N Engl J Med. 2007 Jun 28;356(26):2754-5. doi: 10.1056/NEJMc070201. No abstract available.
PubMed 17596618Froud T, Ricordi C, Baidal DA, Hafiz MM, Ponte G, Cure P, Pileggi A, Poggioli R, Ichii H, Khan A, Ferreira JV, Pugliese A, Esquenazi VV, Kenyon NS, Alejandro R. Islet transplantation in type 1 diabetes mellitus using cultured islets and steroid-free immunosuppression: Miami experience. Am J Transplant. 2005 Aug;5(8):2037-46. doi: 10.1111/j.1600-6143.2005.00957.x.
PubMed 15996257Pfeifer MA, Halter JB, Porte D Jr. Insulin secretion in diabetes mellitus. Am J Med. 1981 Mar;70(3):579-88. doi: 10.1016/0002-9343(81)90579-9.
PubMed 7011013Brunzell JD, Robertson RP, Lerner RL, Hazzard WR, Ensinck JW, Bierman EL, Porte D Jr. Relationships between fasting plasma glucose levels and insulin secretion during intravenous glucose tolerance tests. J Clin Endocrinol Metab. 1976 Feb;42(2):222-9. doi: 10.1210/jcem-42-2-222.
PubMed 1262429Godsland IF, Jeffs JAR, Johnston DG. Loss of beta cell function as fasting glucose increases in the non-diabetic range. Diabetologia. 2004 Jul;47(7):1157-1166. doi: 10.1007/s00125-004-1454-z. Epub 2004 Jul 13.
PubMed 15249997Moran A, Zhang HJ, Olson LK, Harmon JS, Poitout V, Robertson RP. Differentiation of glucose toxicity from beta cell exhaustion during the evolution of defective insulin gene expression in the pancreatic islet cell line, HIT-T15. J Clin Invest. 1997 Feb 1;99(3):534-9. doi: 10.1172/JCI119190.
PubMed 9022089Donath MY, Gross DJ, Cerasi E, Kaiser N. Hyperglycemia-induced beta-cell apoptosis in pancreatic islets of Psammomys obesus during development of diabetes. Diabetes. 1999 Apr;48(4):738-44. doi: 10.2337/diabetes.48.4.738.
PubMed 10102689Pick A, Clark J, Kubstrup C, Levisetti M, Pugh W, Bonner-Weir S, Polonsky KS. Role of apoptosis in failure of beta-cell mass compensation for insulin resistance and beta-cell defects in the male Zucker diabetic fatty rat. Diabetes. 1998 Mar;47(3):358-64. doi: 10.2337/diabetes.47.3.358.
PubMed 9519740El-Assaad W, Buteau J, Peyot ML, Nolan C, Roduit R, Hardy S, Joly E, Dbaibo G, Rosenberg L, Prentki M. Saturated fatty acids synergize with elevated glucose to cause pancreatic beta-cell death. Endocrinology. 2003 Sep;144(9):4154-63. doi: 10.1210/en.2003-0410.
PubMed 12933690Boden G, Chen X. Effects of fat on glucose uptake and utilization in patients with non-insulin-dependent diabetes. J Clin Invest. 1995 Sep;96(3):1261-8. doi: 10.1172/JCI118160.
PubMed 7657800Boden G, Jadali F, White J, Liang Y, Mozzoli M, Chen X, Coleman E, Smith C. Effects of fat on insulin-stimulated carbohydrate metabolism in normal men. J Clin Invest. 1991 Sep;88(3):960-6. doi: 10.1172/JCI115399.
PubMed 1885781
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation
- ClinicalTrials.gov ID
- NCT01123122
- Acronym / sponsor ID
- VGHEndo0510
- Conditions
- Diabetes Mellitus, Type 1, Islet Transplantation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vancouver Coastal HealthOther government
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 14 May 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.
Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict glucose control | Active comparator | Other: Strict glucose control |
| Standard glucose control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age
- more than 5 years since diagnosis of diabetes
- c-peptide negative
Key exclusion criteria (4 listed)
- ischemic heart disease
- previous transplant
- recurrent infections
- malignancy (except basal or squamous skin cancer)
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 |
|---|---|---|
| Strict glucose controlBlood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation. | Other | Strict glucose control |
Primary outcome
Islet cell function
Time frame: Three months
Function will be assessed three months post-transplantation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Background: PubMed 10911004Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
- Background: PubMed 14568760Shapiro AM, Ricordi C, Hering B. Edmonton's islet success has indeed been replicated elsewhere. Lancet. 2003 Oct 11;362(9391):1242. doi: 10.1016/S0140-6736(03)14526-6. No abstract available.
- Background: PubMed 15983207Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.
- Background: PubMed 15616016Rickels MR, Schutta MH, Markmann JF, Barker CF, Naji A, Teff KL. beta-Cell function following human islet transplantation for type 1 diabetes. Diabetes. 2005 Jan;54(1):100-6. doi: 10.2337/diabetes.54.1.100.
- Background: PubMed 17596618Eich T, Eriksson O, Lundgren T; Nordic Network for Clinical Islet Transplantation. Visualization of early engraftment in clinical islet transplantation by positron-emission tomography. N Engl J Med. 2007 Jun 28;356(26):2754-5. doi: 10.1056/NEJMc070201. No abstract available.
- Background: PubMed 15996257Froud T, Ricordi C, Baidal DA, Hafiz MM, Ponte G, Cure P, Pileggi A, Poggioli R, Ichii H, Khan A, Ferreira JV, Pugliese A, Esquenazi VV, Kenyon NS, Alejandro R. Islet transplantation in type 1 diabetes mellitus using cultured islets and steroid-free immunosuppression: Miami experience. Am J Transplant. 2005 Aug;5(8):2037-46. doi: 10.1111/j.1600-6143.2005.00957.x.
- Background: PubMed 7011013Pfeifer MA, Halter JB, Porte D Jr. Insulin secretion in diabetes mellitus. Am J Med. 1981 Mar;70(3):579-88. doi: 10.1016/0002-9343(81)90579-9.
- Background: PubMed 1262429Brunzell JD, Robertson RP, Lerner RL, Hazzard WR, Ensinck JW, Bierman EL, Porte D Jr. Relationships between fasting plasma glucose levels and insulin secretion during intravenous glucose tolerance tests. J Clin Endocrinol Metab. 1976 Feb;42(2):222-9. doi: 10.1210/jcem-42-2-222.
- Background: PubMed 15249997Godsland IF, Jeffs JAR, Johnston DG. Loss of beta cell function as fasting glucose increases in the non-diabetic range. Diabetologia. 2004 Jul;47(7):1157-1166. doi: 10.1007/s00125-004-1454-z. Epub 2004 Jul 13.
- Background: PubMed 9022089Moran A, Zhang HJ, Olson LK, Harmon JS, Poitout V, Robertson RP. Differentiation of glucose toxicity from beta cell exhaustion during the evolution of defective insulin gene expression in the pancreatic islet cell line, HIT-T15. J Clin Invest. 1997 Feb 1;99(3):534-9. doi: 10.1172/JCI119190.
- Background: PubMed 10102689Donath MY, Gross DJ, Cerasi E, Kaiser N. Hyperglycemia-induced beta-cell apoptosis in pancreatic islets of Psammomys obesus during development of diabetes. Diabetes. 1999 Apr;48(4):738-44. doi: 10.2337/diabetes.48.4.738.
- Background: PubMed 9519740Pick A, Clark J, Kubstrup C, Levisetti M, Pugh W, Bonner-Weir S, Polonsky KS. Role of apoptosis in failure of beta-cell mass compensation for insulin resistance and beta-cell defects in the male Zucker diabetic fatty rat. Diabetes. 1998 Mar;47(3):358-64. doi: 10.2337/diabetes.47.3.358.
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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.
David M Thompson, MD principal investigator
Vancouver General Hospital Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, Type 1 and Islet Transplantation, run by Vancouver Coastal Health at 1 site in Canada.
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 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: withdrawn, as of the sponsor's last update on 1 Apr 2015. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Islet cell function (time frame: Three months). 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 NCT01123122, which also lists 26 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 1 Apr 2015.