drugset / Trial / NCT02682901

Bromocriptine-QR Therapy on Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects

NCT02682901

Phase 4 Completed 84 enrolled Eastern Virginia Medical School
RandomizedParallel-groupTriple-blindTreatment

Summary

The main objective is to demonstrate the effects of early dopaminergic activation on the autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes. The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function measured by assessing sympathetic and parasympathetic function using conventional measures of autonomic function, including power spectral analysis of heart rate as well as peripheral autonomic function using sudorimetry and laser scanning of peripheral microvascular autonomic control.

Timeline

Start
2015-10-05
Primary completion
2018-11-15
Completion
2018-11-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bromocriptine Small molecule 1.6 mg
Comparator Bromocriptine Small molecule 3.2 mg