Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
ConditionInsulin Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYale University
About this trial
This study aims to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp).
Eligibility criteria
Qualifiers
Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent
All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor agonists.
A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or
Disqualifiers
BMI >40kg/m2.
Untreated proliferative retinopathy
Creatinine clearance < 60 ml/min/1.73 m2.
Serum creatinine ≥1.5 mg/dL
Trial design
Treatments tested in this trial
- Ultrasound
- OGTT with unlabeled glucose and liver NMR
- OGTT with carbon-13 labeled glucose and liver NMR
- CGM glucose reading
- HEC - Hyperinsulinemic-Euglycemic-Clamp
Treatment groups
77 Participants
are divided into 4 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov