Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06042517

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Led by Yale University · Updated on 2025-05-08

77

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Type 2 diabetic subjects aged 18 to 80 years who can provide written informed consent
  • Diagnosed with type 2 diabetes for at least 3 months before enrollment
  • Managed with diet and exercise or oral antidiabetic agents only, not on insulin or GLP-1 receptor agonists
  • Have abnormal glucose control diagnosed by standard criteria including fasting plasma glucose, OGTT, random plasma glucose with symptoms, or HbA1c levels
  • Willing to wear a continuous glucose monitor for at least 10 days
  • Willing to follow study instructions and attend laboratory assessments including euglycemic clamps and OGTT
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 40 kg/m2
  • Untreated proliferative retinopathy
  • Creatinine clearance less than 60 ml/min/1.73 m2
  • Serum creatinine of 1.5 mg/dL or higher
  • Positive pregnancy test, breastfeeding, or not using effective contraception
  • Active infections including hepatitis B, hepatitis C, or HIV
  • History of active alcohol abuse
  • History of non-adherence to prescribed medical regimens
  • Baseline hemoglobin less than 10.5 g/dL in females or less than 13 g/dL in males
  • History of bleeding disorders or need for long-term anticoagulant therapy (except low-dose aspirin)
  • Unstable cardiac disease requiring medication changes; stable cardiac conditions allowed
  • Liver function tests exceeding three times the upper limit of normal
  • Gastrointestinal disorders affecting medication absorption or prior upper GI surgery changing anatomy
  • Any medical condition or medication judged by investigators to interfere with study safety or outcomes

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Trial Site Locations

Total: 1 location

1

Yale School of Medicine

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

R

Raimund Herzog, MD MHS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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