Clinical trial NCT02544321: Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Official title: Bromocriptine Quick Release (QR) as Adjunct Therapy in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2015-09-09
Enrollment: 108
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Glucose
timeFrame: 4 weeks
measure: Insulin Dosing
timeFrame: 4 weeks
measure: Brachial Artery Distensibility
timeFrame: 4 weeks
measure: Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean Glycemic Variability
timeFrame: 4 weeks
measure: Hypoglycemia Awareness
timeFrame: 4 weeks
measure: Augmentation Index
timeFrame: 4 weeks
measure: Heart Rate Variability (Adults)
timeFrame: 4 weeks
measure: Heart Rate Variability (Adolescents)
timeFrame: 4 weeks
measure: Sleep Duration
timeFrame: 4 weeks
measure: Sleep Quality
timeFrame: 4 weeks
measure: Metabolic Markers-glucose and Triglycerides
timeFrame: 4 weeks
measure: Metabolic Markers-fatty Acids
timeFrame: 4 weeks
measure: Metabolic Markers-glucagon
timeFrame: 4 weeks
measure: Metabolic Markers - GLP1
timeFrame: 4 weeks
measure: Metabolic Markers - Insulin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado-Denver, Anshutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Irene Schauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Colorado/University of Colorado
name: Kristen Nadeau, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tell SS, Schafer M, Vigers T, Baumgartner AD, Lyon E, Gross S, Polsky S, Snell-Bergeon JK, Schauer IE, Nadeau KJ. Bromocriptine quick-release as adjunct therapy in youth and adults with type 1 diabetes: A randomized, placebo-controlled crossover study. Diabetes Obes Metab. 2022 Nov;24(11):2148-2158. doi: 10.1111/dom.14800. Epub 2022 Jul 25.