Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
| Status: | Withdrawn |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 70 |
| Updated: | 7/28/2018 |
| Start Date: | August 2009 |
| End Date: | August 2011 |
Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus
Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid
organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate
in response to variations in doses of steroid and other immunosuppressive agents. At the same
time, poorly controlled hyperglycemia affects negatively graft function and survival as well
as on the ability of the immunocompromised host to fight infections. The investigators
hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM
would help patients with post-transplant diabetes attain better control at the critical time
of titration of immunosuppressive regimens. The primary objective of this proposal is to
improve glycemic control of diabetes with Pramlintide in patients with post-transplant
diabetes at 3 and 6 months of therapy.
organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate
in response to variations in doses of steroid and other immunosuppressive agents. At the same
time, poorly controlled hyperglycemia affects negatively graft function and survival as well
as on the ability of the immunocompromised host to fight infections. The investigators
hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM
would help patients with post-transplant diabetes attain better control at the critical time
of titration of immunosuppressive regimens. The primary objective of this proposal is to
improve glycemic control of diabetes with Pramlintide in patients with post-transplant
diabetes at 3 and 6 months of therapy.
Inclusion Criteria:
- Post-transplant diabetes (PTMD)
- Aged 20-70
- Diagnosis of diabetes within the last 6-18 months
- Stable medications
- Stable weight for 3 months
- Serum creatinine < 1.5 mg/dL
Exclusion Criteria:
- Pre-transplant diabetes
- Major postoperative complications following transplant
- Pregnancy
- Significant GI discomfort with nausea or vomiting
- Inability to learn continuous glucose monitoring
- Development of diabetes more than 4 years after transplant
- omen of child-bearing potential who use birth control pills and have fasting
triglycerides of > 400 mg/dL
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