Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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