Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Description

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).

Conditions

Insulin Sensitivity

Study Overview

Study Details

Study overview

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).

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Condition
Insulin Sensitivity
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Subjects must demonstrate:
  • 1. A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:
  • * 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
  • * A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis or
  • * A hemoglobin A1c (HbA1c) level of 6.5% or higher.
  • 2. Be willing to carry a continuous glucose monitor for at least 10 days.
  • 3. Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
  • * BMI \>40kg/m2.
  • * Untreated proliferative retinopathy
  • * Creatinine clearance \< 60 ml/min/1.73 m2.
  • * Serum creatinine ≥1.5 mg/dL
  • * Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
  • * Active infection including hepatitis C, hepatitis B, HIV,
  • * Any history of Active alcohol abuse
  • * History of non-adherence to prescribed regimens
  • * Baseline Hgb \< 10.5 g/dL in females, or \< 13 g/dL in males
  • * History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
  • * Co-existing cardiac disease with active medication titration. Patients on stable meds without active cardiac complications permitted.
  • * Liver function tests outside of 3xUL of normal range
  • * GI disorders potentially interfering with the ability to absorb oral medications and h/o upper GI surgery that might have changed anatomy in the target areas.
  • * Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Raimund Herzog, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2027-09-30