RECRUITING

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Quick Facts

Study Start:2023-09-30

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06042517

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Raimund Herzog, MD MHS

CONTACT

+1 (203) 737-4773

raimund.herzog@yale.edu

Principal Investigator

Raimund Herzog, MD, MHS

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale School of Medicine

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Raimund Herzog, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-30

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-09-30

Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

Insulin Sensitivity