Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 60 |
| Updated: | 6/22/2018 |
| Start Date: | September 2015 |
| End Date: | December 2018 |
| Contact: | Ellen Lyon, MS |
| Email: | ellen.lyon@ucdenver.edu |
| Phone: | 720-848-6690 |
Bromocriptine Quick Release (QR) as Adjunct Therapy in Type 1 Diabetes
Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance
(IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
exciting development, representing a novel mechanism for improving IR. BCQR has not been
studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
will include fasting and postprandial glucose, glycemic variability, insulin dosing,
hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
(IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
exciting development, representing a novel mechanism for improving IR. BCQR has not been
studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
will include fasting and postprandial glucose, glycemic variability, insulin dosing,
hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
Inclusion Criteria:
1. Type 1 Diabetes (T1D) of >1 year duration based on a clinical course consistent with
T1D and rapid conversion to insulin requirement after diagnosis.
2. HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)
3. age 12-60 years of age
Exclusion Criteria:
1. Any comorbid condition associated with inflammation, insulin resistance, or
dyslipidemia including cancer, heart failure, active or end stage liver disease,
kidney disease (except microalbuminuria), inadequately treated thyroid disease, or
rheumatologic disease;
2. Tobacco or marijuana use;
3. Pregnancy;
4. Regular or frequent oral steroid use;
5. Current use of insulin sensitizing medications, neuroleptics, ergot-related
medications, or triptan medications for migraine,
6. Diagnosis or history of psychosis,
7. Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic
fibrosis-related diabetes.
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